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

Phase 4

• Conditions: Varicella
• Interventions: Biological: Live Attenuated Varicella Vaccine

• Registration Number: NCT06484686
• Lead Sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd.

Brief Summary

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

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 Timeline

• Study First Submitted: 2024-06-26
• Study First Submitted QC: 2024-06-26
• Study First Posted: 2024-07-03
• Study Start: 2024-09-16
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-27
• Primary Completion: 2028-12
• Study Completion: 2031-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 414

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental Group	Live Attenuated Varicella Vaccine	Subjects will be collected venous blood at 6 and 10 years after booster immunization.

Primary Outcome Measures

Name	Time	Method
Seropositive rate	at 10 years after booster vaccination	The seropositive rate of VZV antibodies at 10 years after booster vaccination
GMT of VZV antibody	at 10 years after booster vaccination	The GMT of VZV antibodies at 10 years after booster vaccination

Trial Locations

Locations (1)

Henan Provincial Center for Disease Control and Prevention; 🇨🇳 Zhengzhou, Henan, China