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

Phase 3

Completed

• Conditions: Varicella
• Interventions: Biological: Investigational live attenuated varicella vaccine; Biological: diluent of lyophilized vaccine

• Registration Number: NCT02981836
• Lead Sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd.

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-08
• Status Verified: 2016-11
• Study First Submitted: 2016-11-28
• Study First Submitted QC: 2016-11-30
• Study First Posted: 2016-12-05
• Primary Completion: 2017-06
• Study Completion: 2017-09
• Last Update Submitted: 2017-10-24
• Last Update Posted: 2017-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5997

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:

  1. Any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
  2. Any live attenuated vaccine within 1 month prior to study entry;
  3. 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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Investigational live attenuated varicella vaccine	* Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0; * Intervention: investigational live attenuated varicella vaccine;
Control Group	diluent of lyophilized vaccine	* Single intramuscular injection of the diluent of lyophilized vaccine (0.5 ml) on Day 0; * Intervention: diluent of lyophilized vaccine;

Primary Outcome Measures

Name	Time	Method
The protection rate of the vaccine	≥30 cases reported after 30 days of the injection	The protection rate will be calculated based on the reported cases occurred 30 days after injection.
The incidences of varicella of each group	≥30 cases reported 30 days after injection	The first 30 cases of varicella occurred 30 days after injection will be collected.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Biyang County Center for Disease Control and Prevention; 🇨🇳 Zhumadian, Henan, China

Xiangcheng County Center for Disease Control and Prevention; 🇨🇳 Xuchang, Henan, China