A Blind, Randomized and Controlled Study of Live Attenuated Varicella Vaccines

Last updated: October 24, 2017
Sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Throat And Tonsil Infections

Rash

Shingles

Treatment

N/A

Clinical Study ID

NCT02981836
PRO-VZV-3001
  • Ages 1-12
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to evaluate the protective effect, safety and immunogenicity of a live attenuated varicella vaccine in healthy children.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy volunteer between 1 - 12 years old;

  • Proven legal identity;

  • Guardian(s) of the volunteer and/or volunteers themselves should be capable ofunderstanding the written consent form, and such form should be signed before thevolunteer being included into this study;

Exclusion

Exclusion Criteria:

  • Prior vaccination with varicella vaccine or with history of varicella zoster virus (VZV) infection;

  • Axillaty temperature > 37.0 °C;

  • History of allergy to any vaccine or vaccine ingredient, or serious adversereaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneuroticedema, abdominal pain, etc;

  • History of epilepsy, seizures or convulsions, or a family history of mental illness,autoimmune disease or immunodeficiency;

  • Severe malnutrition, congenital malformation, developmental disorders, or seriouschronic diseases;

  • Acute disease or acute stage of chronic disease within 7 days prior to study entry;

  • Receipt of any of the following products:

  1. Any subunit vaccine or inactivated vaccine within 7 days prior to study entry;

  2. Any live attenuated vaccine within 1 month prior to study entry;

  3. Any blood product, immunosuppressant, hormone, or other investigationalmedicine(s) within 30 days prior to study entry;

  • Any significant abnormity of heart, lung, skin, or pharynx;

  • Any other factor that suggesting the volunteer is unsuitable for this study based onthe opinions of investigators;

Study Design

Total Participants: 5997
Study Start date:
August 01, 2016
Estimated Completion Date:
September 30, 2017

Study Description

This study is a randomized, blind, controlled phase III clinical trial. The purpose of this study is to evaluate the protective effect, safety and immunogenicity of a live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The control is diluent of lyophilized vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. All participants are healthy, and will be randomly assigned into experimental group or control group in the ratio 1:1.

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

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