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

January 23, 2025 updated by: Sinovac (Dalian) Vaccine Technology Co., Ltd.

An Open-label Clinical Trial to Evaluate the Immunity Persistence of Live Attenuated Varicella Vaccine At 6 and 10 Years After Booster Dose Immunization with Live Attenuated Varicella Vaccine

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

414

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450016
        • Henan Provincial Center for Disease Control and Prevention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
Subjects will be collected venous blood at 6 and 10 years after booster immunization.
Biological: Live Attenuated Varicella Vaccine
lyophilized powder, subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seropositive rate
Time Frame: at 6 years after booster vaccination
The seropositive rate of varicella-zoster virus (VZV) antibodies at 6 years after booster vaccination
at 6 years after booster vaccination
Seropositive rate
Time Frame: at 10 years after booster vaccination
The seropositive rate of VZV antibodies at 10 years after booster vaccination
at 10 years after booster vaccination
GMT of VZV antibody
Time Frame: at 6 years after booster vaccination
The GMT of VZV antibodies at 6 years after booster vaccination
at 6 years after booster vaccination
GMT of VZV antibody
Time Frame: at 10 years after booster vaccination
The GMT of VZV antibodies at 10 years after booster vaccination
at 10 years after booster vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sinovac (Dalian) Vaccine Technology Co., Ltd.

Investigators

  • Principal Investigator: Lili Huang, Henan Provincial Center for Disease Control and Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2024

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2031

Study Registration Dates

First Submitted

June 26, 2024

First Submitted That Met QC Criteria

June 26, 2024

First Posted (Actual)

July 3, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 23, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO-VZV-4005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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