An Immunity Persistence Study of Live Attenuated Varicella Vaccine

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

Phase

4

Condition

Throat And Tonsil Infections

Rash

Shingles

Treatment

Investigational Live Attenuated Varicella Vaccine

Placebo (Freeze Dired Dilution)

Clinical Study ID

NCT05095701
PRO-VZV-4004
  • Ages 1-17
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This an open phase Ⅳ clinical trial of live attenuated varicella vaccines 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 5 and 8 years after primary immunization with live attenuated varicella vaccine.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects in PPS immunogenicity subgroup of phase Ⅲ clinical trial of protectiveeffect of varicella vaccine;

  • The subject and/or guardian can understand and voluntarily sign the informed consentform;

  • Proven legal identity.

Exclusion

Exclusion Criteria:

  • History of chickenpox or shingles;

  • History of varicella vaccination since phase Ⅲ clinical trial;

  • Autoimmune disease or immunodeficiency / immunosuppression;

  • History of immunosuppressive therapy 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: 703
Treatment Group(s): 2
Primary Treatment: Investigational Live Attenuated Varicella Vaccine
Phase: 4
Study Start date:
December 18, 2021
Estimated Completion Date:
October 01, 2025

Study Description

This study is an open phase Ⅳ clinical trial in subjects who enrolled in the clinical trial and included in the immunogenicity subgroup PPS set from August to September 2016 .The experimental vaccine and placebo (Freeze Dired Dilution) were manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.A total of 703 subjects will be enrolled including 349 subjects in experimental group and 354 subjects in control group .And 3.0-3.5ml of venous blood was collected from all subjects at 5 and 8 years after primary immunization, and the serum was separated for varicella antibody detection. The window period of blood collection was six months.

Connect with a study center

  • Xiangcheng County Center for Disease Control and Prevention

    Xuchang, Henan 461700
    China

    Site Not Available

  • Biyang County Center for Disease Control and Prevention

    Zhumadian, Henan 463700
    China

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.