An Open-labelled Clinical Trial of Live Attenuated Varicella Vaccines to Evaluate the Immunity Persistence After Primary Immunization and Safety and Immunogenicity After the Booster Immunization

An Open-labelled Clinical Trial,to Evaluate the Immunity Persistence of the Single-dose Primary Immunization of Live Attenuated Varicella Vaccine on Different Time Points,and the Safety and Immunogenicity After the Booster Immunization

This is an open-labelled 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 the single-dose primary immunization of live attenuated varicella vaccine on different time points ,and the safety and immunogenicity after the booster immunization

Study Overview

• Status: Completed
• Conditions: Varicella
• Intervention / Treatment: Biological: Investigational live attenuated varicella vaccine

Detailed Description

This study is an open-labelled phase Ⅲ clinical trial.The experimental vaccine manufactured by Sinovac(Dalian) Vaccine Technology Co., Ltd.A total of 1195 subjects who received vaccine in the phase Ⅲ lot-consistency clinical trial were be enrolled .All subjects except C0243 and C0556 were divided into 3 groups according to the order of study number.Subjects in 3 groups received a booster immunization of live attenuated varicella vaccines 1 year,2 years and 3 years after primary immunization,respectively.About 3.0ml of venous blood was collected from each enrolled subject at pre-booster immunization,30 days after booster immunization and the serum was separated for neutralizing antibody detection.The antibody levels were used to evaluate the immunity persistence and immunogenicity after booster immunization of live attenuated varicella vaccines .

• Study Type: Interventional
• Enrollment (Actual): 1193
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Henan
    • Kaifeng, Henan, China, 461700
      • Xiangfu County Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 6 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Received one dose live attenuated varicella vaccine in the phase Ⅲ lot-consistency clinical trial;
• Guardian(s) of the volunteer should be capable of understanding the written - consent form, and such form should be signed before the children being included into this study.

Exclusion Criteria:

• Received one dose live attenuated varicella vaccine at the end of the phase Ⅲ lot-consistency 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

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Booster immunization 1 year after primary immunization; Subjects C0001-C0400 except C0243 received 1 dose of booster immunization 1 year after primary immunization.	Biological: Investigational live attenuated varicella vaccine; The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.And the live varicella-zoster virus in 0·5 mL of sucrose, sodium glutamate,sodium chloride,potassium chloride,sodium dihydrogen phosphate, potassium dihydrogen phosphate and injection water per injection
Experimental: Booster immunization 2 year after primary immunization; Subjects C0401-C0800 except C0556 received 1 dose of booster immunization 2 years after primary immunization.	Biological: Investigational live attenuated varicella vaccine; The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.And the live varicella-zoster virus in 0·5 mL of sucrose, sodium glutamate,sodium chloride,potassium chloride,sodium dihydrogen phosphate, potassium dihydrogen phosphate and injection water per injection
Experimental: Booster immunization 3 year after primary immunization; Subjects C0801-C1197 received 1 dose of booster immunization 3 years after primary immunization.	Biological: Investigational live attenuated varicella vaccine; The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.And the live varicella-zoster virus in 0·5 mL of sucrose, sodium glutamate,sodium chloride,potassium chloride,sodium dihydrogen phosphate, potassium dihydrogen phosphate and injection water per injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity index-seroconversion rate of antibody	seroconversion rates of antibody 1 year after primary immunization	1 year after primary immunization
Immunogenicity index-seroconversion rate of antibody	seroconversion rates of antibody 2 years after primary immunization	2 years after primary immunization
Immunogenicity index-seroconversion rate of antibody	seroconversion rates of antibody 3 years after primary immunization	3 years after primary immunization
Immunogenicity index-Seroconversion rate of antibody	Seroconversion rate of the neutralizing antibody 30 days after booster immunization	30 days after booster immunization
Immunogenicity index-seropositivity rate of antibody	Seropositivity rate of antibody 30 days after booster immunization	30 days after booster immunization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity index-Seropositivity rate of antibody	Seropositivity rate of antibody before booster immunization	Before the booster dose immunization
Immunogenicity index-GMT of the antibody	GMT of the antibody before booster immunization	Before the booster dose immunization
Immunogenicity index- GMT of the antibody	GMT of the antibody 30 days after booster immunization	30 days after booster immunization
Immunogenicity index- GMI of the antibody	GMI of the antibody 30 days after booster immunization	30 days after booster immunization
Safety index-Incidence of solicited local or systemic AE	Incidence of solicited local or systemic AE within 14 days after vaccination	within 14 days after vaccination
Safety index-Incidence of local or systemic AE	Incidence of local or systemic AE within 30 days after vaccination	within 30 days after vaccination
Safety index-Incidence of SAE	Incidence of SAE within 30 days after vaccination	within 30 days after vaccination

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2018
• Primary Completion (Actual): August 11, 2018
• Study Completion (Actual): August 14, 2020

Study Registration Dates

• First Submitted: November 22, 2021
• First Submitted That Met QC Criteria: December 8, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Actual): December 9, 2021
• Last Update Submitted That Met QC Criteria: December 8, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Herpesviridae Infections; Varicella Zoster Virus Infection; Herpes Zoster; Chickenpox
• Other Study ID Numbers: PRO-VZV-3002-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No