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

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

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

Study Overview

• Status: Completed
• Conditions: Varicella
• Intervention / Treatment: Biological: Investigational live attenuated varicella vaccine; Biological: diluent of lyophilized vaccine

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 Type: Interventional
• Enrollment (Actual): 5997
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Henan
    • Xuchang, Henan, China, 461700
      • Xiangcheng County Center for Disease Control and Prevention
    • Zhumadian, Henan, China, 463700
      • Biyang County Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; 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; The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.
Sham Comparator: Control Group; 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; The diluent of lyophilized vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd.

Publications and helpful links

General Publications

• Zhang Y, Wang L, Wang Y, Zhang W, Jia N, Xie Z, Huang L, You W, Lu W, Li E, Gao F, Hu Y, Meng F, Xia S. Immunogenicity and Safety of a Booster Dose of Live Attenuated Varicella Vaccine, and Immune Persistence of a Primary Dose for Children Aged 2 to 6 Years. Vaccines (Basel). 2022 Apr 22;10(5):660. doi: 10.3390/vaccines10050660.
• Hao B, Chen Z, Zeng G, Huang L, Luan C, Xie Z, Chen J, Bao M, Tian X, Xu B, Wang Y, Wu J, Xia S, Yuan L, Huang J. Efficacy, safety and immunogenicity of live attenuated varicella vaccine in healthy children in China: double-blind, randomized, placebo-controlled clinical trial. Clin Microbiol Infect. 2019 Aug;25(8):1026-1031. doi: 10.1016/j.cmi.2018.12.033. Epub 2019 Jan 4.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: November 28, 2016
• First Submitted That Met QC Criteria: November 30, 2016
• First Posted (Estimate): December 5, 2016

Study Record Updates

• Last Update Posted (Actual): October 26, 2017
• Last Update Submitted That Met QC Criteria: October 24, 2017
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: safety; live attenuated varicella vaccine; immunogenicity; child; protective effect
• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Herpesviridae Infections; Varicella Zoster Virus Infection; Herpes Zoster; Chickenpox; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: PRO-VZV-3001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No