A Safety Study of Live Attenuated Varicella Vaccines in Healthy Adults, Adolescents and Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety of a live attenuated varicella vaccine in healthy adults, adolescents, and children.

Detailed Description
-----------------
This study is a randomized, blind, single-center, controlled phase I clinical trial. The purpose of this study is to evaluate the safety of a live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The positive control is a commercialized live attenuated varicella vaccine manufactured by Shanghai Institute of Biological Products Co., Ltd. (SIBP), and the negative 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, positive control group, or negative control group in the ratio 1:1:1.

Official Title
-----------------
A Blind, Randomized and Controlled Clinical Trial to Evaluate the Safety of Live Attenuated Varicella Vaccines for Healthy Adults, Adolescents and Children

Conditions
-----------------
Varicella

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteer between 1 - 49 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 infant 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; Breast feeding, pregnant, or expected to conceive during the period of this trial; 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 of the pre-immune test results of the following indexes of laboratory tests showed clinically significant abnormity: Blood routine examinations: hemoglobin (Hb), white blood cells (WBC) count; Blood biochemistry detections: alanine transferase (ALT), total bilirubin, blood urea nitrogen (BUN), creatinine; Urine routine tests: urine protein, urine glucose, urine erythrocyte Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators;

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 49 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

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>|
| Active Comparator: Positive Control Group<br>Single intramuscular injection of the control vaccine (0.5 ml) on Day 0; Intervention: control live attenuated varicella vaccine. | Biological: control live attenuated varicella vaccine<br>* The control vaccine was manufactured by Shanghai Institute of Biological Products Co., Ltd. (SIBP)<br>|
| Sham Comparator: Negative 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<br>|

What is the study measuring?
-----------------
Primary 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidences of abnormal results of lab tests | Cases of abnormal results of laboratory tests will be collected. | 30 days | 
| The incidences of serious adverse events (SAEs) of each group | SAEs occurred within 30 days after injection will be collected. | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
live attenuated varicella vaccine, safety, adult, adolescent, child