An Immunity Persistence Study of Live Attenuated Varicella Vaccine

An Open Clinical Trial to Evaluate the Immunity Persistence of Live Attenuated Varicella Vaccine At 5 and 8 Years After Primary Immunization with Live Attenuated Varicella Vaccine

This an open phase Ⅳ clinical trial of live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd .The purpose of this study is to evaluate the immunity persistence of live attenuated varicella vaccine at 5 and 8 years after primary immunization with live attenuated varicella vaccine.

Study Overview

• Status: Enrolling by invitation
• Conditions: Varicella
• Intervention / Treatment: Biological: Investigational Live Attenuated Varicella Vaccine; Biological: Placebo (Freeze Dired Dilution)

Detailed Description

This study is an open phase Ⅳ clinical trial in subjects who enrolled in the clinical trial and included in the immunogenicity subgroup PPS set from August to September 2016 .The experimental vaccine and placebo (Freeze Dired Dilution) were manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.A total of 703 subjects will be enrolled including 349 subjects in experimental group and 354 subjects in control group .And 3.0-3.5ml of venous blood was collected from all subjects at 5 and 8 years after primary immunization, and the serum was separated for varicella antibody detection. The window period of blood collection was six months.

• Study Type: Interventional
• Enrollment (Estimated): 703
• Phase: Phase 4

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 17 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Subjects in PPS immunogenicity subgroup of phase Ⅲ clinical trial of protective effect of varicella vaccine;
• The subject and/or guardian can understand and voluntarily sign the informed consent form;
• Proven legal identity.

Exclusion Criteria:

• History of chickenpox or shingles;
• History of varicella vaccination since phase Ⅲ clinical trial;
• Autoimmune disease or immunodeficiency / immunosuppression;
• History of immunosuppressive therapy since phase Ⅲ clinical trial;
• According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; 349 subjects who enrolled in the experimental group of clinical trial and included in the immunogenicity subgroup PPS set from August to September 2016 will be collected venous blood 3.0~3.5ml at 5 and 8 years after primary immunization.	Biological: Investigational Live Attenuated Varicella Vaccine; The live attenuated varicella vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. Live attenuated varicella-virus in 0·5 mL injection water with sucrose,sodium glutamate,sodium chloride,potassium chloride, sodium dihydrogen phosphate, potassium dihydrogen phosphate per injection.
Placebo Comparator: Control Group; 354 subjects who enrolled in the control group of clinical trial and included in the immunogenicity subgroup PPS set from August to September 2016 will be collected venous blood 3.0~3.5ml at 5 and 8 years after primary immunization.	Biological: Placebo (Freeze Dired Dilution); The placebo (freeze dired dilution) was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. and contained no active ingredient.It was 0·5 mL injection water with sucrose,sodium glutamate,sodium chloride,potassium chloride and phosphate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity index-seropositive rates of varicella antibody	The seropositive rates of varicella antibody in 5 years after primary immunization with varicella vaccine	5 years after primary immunization
Immunogenicity index-GMT of varicella antibody	GMT of varicella antibody in 5 years after primary immunization with varicella vaccine	5 years after primary immunization
Immunogenicity index-the seropositive rates of varicella antibody	The seropositive rates of varicella antibody in 8 years after primary immunization with varicella vaccine	8 years after primary immunization
Immunogenicity index-the GMT of varicella antibody	GMT of varicella antibody in 8 years after primary immunization with varicella	8 years after primary immunization

Collaborators and Investigators

• Sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd.
• Investigators: Principal Investigator: Lili Huang, Bachelor, Henan Provincial Center for Disease Prevention and Control

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2021
• Primary Completion (Actual): December 19, 2021
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: October 14, 2021
• First Submitted That Met QC Criteria: October 14, 2021
• First Posted (Actual): October 27, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 23, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Varicella Zoster Virus Infection; Infections; Virus Diseases; DNA Virus Infections; Herpesviridae Infections; Herpes Zoster; Chickenpox
• Other Study ID Numbers: PRO-VZV-4004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No