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

Phase 4Enrolling By InvitationNCT06484686
Sinovac (Dalian) Vaccine Technology Co., Ltd.414 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Enrollment

414

Conditions

Varicella

Interventions

Live Attenuated Varicella VaccineBIOLOGICAL

lyophilized powder, subcutaneous injection

Eligibility

Sex: ALLMin age: 8 YearsMax age: 16 YearsHealthy volunteers:
Medical Language ↔ Plain English
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.

Locations (1)

Henan Provincial Center for Disease Control and Prevention

Zhengzhou, Henan, China

Outcomes

Primary Outcomes

Seropositive rate

The seropositive rate of varicella-zoster virus (VZV) antibodies at 6 years after booster vaccination

Time frame: at 6 years after booster vaccination

Seropositive rate

The seropositive rate of VZV antibodies at 10 years after booster vaccination

Time frame: at 10 years after booster vaccination

GMT of VZV antibody

The GMT of VZV antibodies at 6 years after booster vaccination

Time frame: at 6 years after booster vaccination

GMT of VZV antibody

The GMT of VZV antibodies at 10 years after booster vaccination

Time frame: at 10 years after booster vaccination

Data from ClinicalTrials.gov

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