Safety and Immunogenicity Study of Live Attenuated Vaccine Against Varicella Without Gelatin

Study Overview
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Brief Summary
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The purpose of this study is to observe the occurrence of adverse reaction and antibody positive rate, the elevated level of antibody，Geometric mean titer (GMT) between groups of live attenuated varicella vaccine without gelatin.

Detailed Description
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Observational Objectives: To describe the safety of evaluated vaccine, in children aged ≥ 1th birthday and ≤ 12th birthday. To describe the immunogenicity of evaluated vaccine, in children aged ≥ 1th birthday and ≤ 12th birthday.

Official Title
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Evaluation of Safety and Immunogenicity Receiving Live Attenuated Vaccine Against Varicella Without Gelatin

Conditions
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Chickenpox, Zoster

Intervention / Treatment
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* Biological: vaccine without gelatin
* Biological: vaccine with gelatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent Participant is considered to be in good health including the body and mental status on the basis of reported medical history and limited physical examination and live in local ≥ 12 months Participant is aged ≥ 1 year to ≤ 12 years Body temperature ≤ 37.0℃ Participant without preventive inoculation of varicella vaccine and previous history of chickenpox and zoster Exclusion Criteria: Known allergy to any constituent of the vaccine Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction Known bleeding disorder Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth Participation in any other interventional clinical trial An acute illness with or without fever (temperature > 37.0℃) in the latest week preceding enrollment in the trial Inoculated other vaccines, immunoglobulin or investigational drugs within 4 weeks prior to participation in the study Reported clearly the infection of the upper respiratory tract with 6 months Clinical Manifestation of Metabolic, blood system, lungs, heart, the gastrointestinal tract, nervous system, kidneys, urinary system, endocrine, liver disease or malignant tumor Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vaccine without gelatin<br>use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection | Biological: vaccine without gelatin<br>* use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection<br>Biological: vaccine with gelatin<br>* use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection<br>|
| Active Comparator: vaccine with gelatin<br>use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection | Biological: vaccine without gelatin<br>* use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection<br>Biological: vaccine with gelatin<br>* use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the immunogenicity of evaluated vaccine | The immunologic equivalence of 4weeks after vaccination of influenza virus vaccine was measured in terms of the level of antibody. | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of live attenuated varicella vaccine | The incidence of adverse events was analyzed statistically. | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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varicella vaccine, gelatin