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

Last updated: January 23, 2025
Sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd.
Overall Status: Active - Enrolling

Phase

4

Condition

Chickenpox (Varicella Zoster Infection)

Shingles

Rash

Treatment

Live Attenuated Varicella Vaccine

Clinical Study ID

NCT06484686
PRO-VZV-4005
  • Ages 8-16
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 informedconsent form;

  • Proven legal identity.

Exclusion

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 arenot suitable for participating in the clinical trial.

Study Design

Total Participants: 414
Treatment Group(s): 1
Primary Treatment: Live Attenuated Varicella Vaccine
Phase: 4
Study Start date:
September 16, 2024
Estimated Completion Date:
December 31, 2031

Study 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.

Connect with a study center

  • Henan Provincial Center for Disease Control and Prevention

    Zhengzhou, Henan 450016
    China

    Site Not Available

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