A Blind, Randomized and Controlled Study of Live Attenuated Varicella Vaccines

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the protective effect, safety and immunogenicity of a live attenuated varicella vaccine in healthy children.

Detailed Description
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This study is a randomized, blind, controlled phase III clinical trial. The purpose of this study is to evaluate the protective effect, safety and immunogenicity of a live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The control is diluent of lyophilized vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. All participants are healthy, and will be randomly assigned into experimental group or control group in the ratio 1:1.

Official Title
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A Blind, Randomized and Controlled Clinical Trial to Evaluate the Protective Effect, Safety and Immunogenicity of Live Attenuated Varicella Vaccines for Healthy Children

Conditions
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Varicella

Intervention / Treatment
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* Biological: Investigational live attenuated varicella vaccine
* Biological: diluent of lyophilized vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteer between 1 - 12 years old; Proven legal identity; Guardian(s) of the volunteer and/or volunteers themselves should be capable of understanding the written consent form, and such form should be signed before the volunteer being included into this study; Exclusion Criteria: Prior vaccination with varicella vaccine or with history of varicella zoster virus (VZV) infection; Axillaty temperature > 37.0 °C; History of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc; History of epilepsy, seizures or convulsions, or a family history of mental illness, autoimmune disease or immunodeficiency; Severe malnutrition, congenital malformation, developmental disorders, or serious chronic diseases; Acute disease or acute stage of chronic disease within 7 days prior to study entry; Receipt of any of the following products: Any subunit vaccine or inactivated vaccine within 7 days prior to study entry; Any live attenuated vaccine within 1 month prior to study entry; Any blood product, immunosuppressant, hormone, or other investigational medicine(s) within 30 days prior to study entry; Any significant abnormity of heart, lung, skin, or pharynx; Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators;

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0; Intervention: investigational live attenuated varicella vaccine; | Biological: Investigational live attenuated varicella vaccine<br>* The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.<br>|
| Sham Comparator: Control Group<br>Single intramuscular injection of the diluent of lyophilized vaccine (0.5 ml) on Day 0; Intervention: diluent of lyophilized vaccine; | Biological: diluent of lyophilized vaccine<br>* The diluent of lyophilized vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidences of varicella of each group | The first 30 cases of varicella occurred 30 days after injection will be collected. | ≥30 cases reported 30 days after injection | 
| The protection rate of the vaccine | The protection rate will be calculated based on the reported cases occurred 30 days after injection. | ≥30 cases reported after 30 days of the injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidences of adverse events (AEs) of each group | AEs occurred within 30 days after injection will be collected. | 30 days | 
| The incidences of serious adverse events (SAEs) of each group | SAEs occurred within 6 months after injection will be collected. | 6 months | 
| The seroconversion rate of the immunogenicity group | Seroconversion rate of the immonogenicity group 30 days after injection will be collected. | 30 days after injection | 
| The geometric mean titer (GMT) of the immunogenicity group | Geometric mean titer (GMT) of the immonogenicity group will be collected before and 30 days after injection. | 30 days | 
| The geometric mean fold increase (GMI) of the immunogenicity group | Geometric mean fold increse (GMI) of the immonogenicity group will be calculated based on the geometric mean titer. | 30 days after injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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live attenuated varicella vaccine, protective effect, safety, immunogenicity, child