The Safety and Immunogenicity Research of Live Attenuated Varicella Vaccine After the 2 Doses Vaccination

Study Overview
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Brief Summary
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Through evaluating the immunogenicity and safety for Varicella vaccine two doses immune procedure we could supply scientific and practical evidence for this two doses immune procedure promotion and management.

Detailed Description
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Healthy participants aged 1 to 12 years old who had never received Varicella Vaccine are divided into three age groups, 1 to 3 years old group, 4 to 6 years old group and 7-12 years old group. In each age group, participants are randomly divided into experiment group and control groups.

Official Title
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Phase 4 Study of Live Attenuated Varicella Vaccine After the 2 Doses Vaccination

Conditions
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Varicella

Intervention / Treatment
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* Biological: HBV-3
* Biological: HBV-6
* Biological: varicella-3
* Biological: varicella-6


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Participants from Shanxi province are between 1-12 years old are in good healthy determined through medical inquiry, 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 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 received other live attenuated vaccine vaccination in 30 days before enrollment; Had been infected with Varicella virus and displayed symptom; Have received one or two dose of Varicella vaccine before enrollment; Congenital malformations, growth disorders such as Down's syndrome, diabetes, sickle cell anemia and nervous disorders Guillain-barre syndrome Thyroid resection history or thyroid disease treatment in the past 12 months; Asthma Have participated in other clinical research; Have serious adverse reactions after vaccination, such as allergies, hives, breathing difficulties, angioneurotic edema.

Ages Eligible for Study
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Minimum Age: 1 Year
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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: HBV-3<br>one dose HBV | Biological: HBV-3<br>* Give a single 0.5 mL HBV and get blood samples at 0,1.5,4.5 month<br>|
| Placebo Comparator: HBV-6<br>one dose HBV | Biological: HBV-6<br>* Give a single 0.5 mL HBV and get blood samples at 0,1.5,7.5 month<br>|
| Experimental: varicella-3<br>2 doses varicella vaccine either BCHT or Kengen and 3 month of the interval time | Biological: varicella-3<br>* Give 2 doses varicella vaccine (a single 0.5 mL) and get blood samples at 0,1.5,4.5 month<br>|
| Experimental: varicella-6<br>2 doses varicella vaccine either BCHT or Kengen and 6 month of the interval time | Biological: varicella-6<br>* Give 2 doses varicella vaccine (a single 0.5 mL) and get blood samples at 0,1.5,7.5 month<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody titer after 2 doses lived attenuated varicella vaccination | Serums are collected from all participants before and 42 days after the first vaccination, and also 42 days after the second vaccination. The antibody titer to Varicella was detected through FAMA test. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who have adverse reaction | The safety is evaluated by systemic and local reaction after each vaccination. | 1 year |