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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

NCT ID: NCT05150392

Last Updated: 2021-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1193 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-11

Study Completion Date

2020-08-14

Brief Summary

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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

Detailed Description

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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 .

Conditions

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Varicella

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Booster immunization 1 year after primary immunization

Subjects C0001-C0400 except C0243 received 1 dose of booster immunization 1 year after primary immunization.

Group Type EXPERIMENTAL

Investigational live attenuated varicella vaccine

Intervention Type BIOLOGICAL

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

Booster immunization 2 year after primary immunization

Subjects C0401-C0800 except C0556 received 1 dose of booster immunization 2 years after primary immunization.

Group Type EXPERIMENTAL

Investigational live attenuated varicella vaccine

Intervention Type BIOLOGICAL

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

Booster immunization 3 year after primary immunization

Subjects C0801-C1197 received 1 dose of booster immunization 3 years after primary immunization.

Group Type EXPERIMENTAL

Investigational live attenuated varicella vaccine

Intervention Type BIOLOGICAL

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

Interventions

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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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sinovac (Dalian) Vaccine Technology Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shengli Xia, Master

Role: PRINCIPAL_INVESTIGATOR

Henan Provincial Center for Disease Control and Prevention

Locations

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Xiangfu County Center for Disease Control and Prevention

Kaifeng, Henan, China

Site Status

Countries

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China

Other Identifiers

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PRO-VZV-3002-1

Identifier Type: -

Identifier Source: org_study_id