An Immunity Persistence Study of Booster Dose of Live Attenuated Varicella Vaccine

NCT ID: NCT06484686

Last Updated: 2025-01-27

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

ENROLLING_BY_INVITATION

Clinical Phase

PHASE4

Total Enrollment

414 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-16

Study Completion Date

2031-12-31

Brief Summary

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This an open-label phase Ⅳ clinical trial of live attenuated varicella vaccine 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 6 and 10 years after booster dose.

Detailed Description

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A total of 792 subjects aged 2 to 6 years including in per-protocol set (PPS) of immunogenicity assessment from previous phase Ⅲ clinical trial were enrolled. About 3.0ml of venous blood was collected at 6 and 10 years after booster immunization for antibody detection.

Conditions

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Varicella

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Experimental Group

Subjects will be collected venous blood at 6 and 10 years after booster immunization.

Group Type EXPERIMENTAL

Live Attenuated Varicella Vaccine

Intervention Type BIOLOGICAL

lyophilized powder, subcutaneous injection

Interventions

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Live Attenuated Varicella Vaccine

lyophilized powder, subcutaneous injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Subjects in PPS of previous phase Ⅲ clinical trial of varicella vaccine;
* The subjects and/or guardian can understand and voluntarily sign the informed consent form;
* Proven legal identity.

Exclusion Criteria

* Beyond the blood collection window period;
* History of varicella or shingles;
* History of varicella vaccination 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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

16 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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Lili Huang

Role: PRINCIPAL_INVESTIGATOR

Henan Provincial Center for Disease Control and Prevention

Locations

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Henan Provincial Center for Disease Control and Prevention

Zhengzhou, Henan, China

Site Status

Countries

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China

Other Identifiers

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PRO-VZV-4005

Identifier Type: -

Identifier Source: org_study_id

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