The Safety, Immunogenicity and Immune Effect Research of the Varicella Vaccine After the 2nd Dose Vaccination

Study Overview
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Brief Summary
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To investigate the safety, immunogenicity and immune effect of the Varicella vaccine after the 2nd dose vaccination in Chao yang district, Bei jing, since the 2nd varicella vaccination was promoted by Beijing Center for Disease Control and Prevention in November, 2012.

Detailed Description
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Breakthrough varicella cases and varicella cases were monitored to evaluate the protective effective in a large population. Make the basic evaluation of safety for the two dose of varicella vaccination Monitoring the Varicella virus origin and virus types from illness cases in Chao yang district Make the evaluation of healthy costs reduce for the varicella emergency vaccination after large number of varicella cases occurred.

Official Title
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Phase 4 Study of the Varicella Vaccine After the 2nd Dose Vaccination

Conditions
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Varicella

Intervention / Treatment
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* Biological: varicella vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants were between 4-12 years old Participants were in good healthy determined through medical history, physical examination, clinical judgment of the investor Exclusion Criteria: Having a fever (axillary temperature >37.0℃) before enrollment; Having a disease history of seizures, brain and mental disease and the vaccination history of allergies and convulsions; Antibiotics allergy; Having a problem of intramuscular injection because thrombocytopenia or other blood coagulation disorder; Having immunodeficiency or under immunosuppression therapy, radiation therapy; Having respiratory diseases, acute infection, chronic disease and HIV infection; Having systemic skin rash, skin tinea, herpes; Chronic liver and kidney disease; Heart disease, and severe hypertension; Have received whole blood, plasma or immunoglobulin therapy 3 months before enrollment; Have not received other vaccination in 7 days before enrollment

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 12 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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 dose varicella vaccine<br>The providers would get the 2nd dose since they had one dose varicella vaccine | Biological: varicella vaccine<br>* The providers would get varicella vaccine<br>|
| Experimental: 2 dose varicella vaccine<br>The provider never get the varicella vaccine | Biological: varicella vaccine<br>* The providers would get varicella vaccine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of varicella after 2 dose vaccination | Detection the Varicella virus origin and virus types from illness cases in Chao yang district | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event rate of varicella vaccine after 2 dose injection | Adverse event rate of varicella vaccine after 2 dose injection | 5 years |