Immunogenicity, Safety and Protective Effect of Live Attenuated Varicella Vaccine and Study on Antibody Level and Etiology of Varicella Zoster Virus

Last updated: January 11, 2023
Sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd.
Overall Status: Active - Recruiting

Phase

4

Condition

Rash

Shingles

Herpes Simplex Infections

Treatment

N/A

Clinical Study ID

NCT05460429
PRO-VAR-MA4002-ZJ
  • Ages < 59
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This is Phase 4 clinical trial of live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd .The purpose of this study is to evaluate the immunogenicity and safety of a single dose of varicella vaccine in healthy children aged 1-6 years with different varicella immunization histories, to evaluate the antibody level of varicella-zoster virus in healthy people aged 0-59 years in Zhejiang Province.

Eligibility Criteria

Inclusion

Unified Inclusion Criteria:

  • Participants aged 1-12 years ;
  • The subjects and/or guardians can understand and voluntarily sign the informed consentform (For subjects aged 8-12 years, both subjects and guardians need to sign theinformed consent form) and be able to follow all research procedures;
  • Proven legal identity. Special Inclusion Criteria for each study: Inclusion criteria of the study population for immunogenicity and safety evaluation ofvaricella vaccine:
  • Be able to participate in the whole process of vaccination and blood collection;
  • Healthy children aged 1-3 years with no history of varicella vaccination;
  • Healthy children aged 4-6 years with a history of 1 dose of varicella vaccine. Inclusion criteria for investigation of varicella antibody level:
  • Healthy people aged 0-59 years and participate voluntarily for the study;
  • Have no serious chronic disease or acute disease; Inclusion criteria of the study population for safety evaluation of varicella vaccine massvaccination:
  • Participants aged 1-3 years with no history of varicella vaccination;
  • Participants aged 4-12 years with no history of varicella vaccination or with ahistory of 1 dose of varicella vaccine. Inclusion criteria of study population for protective effect of varicella vaccine afterexposure:
  • Children aged 1-12 years exposed to varicella outbreaks;
  • History with no varicella or shingles; Inclusion criteria of study population for etiological study on the pathogenic strains ofvaricella cases:
  • Clinical cases of varicella consent for herpes zoster or pharyngeal swab collection.

Exclusion

Exclusion Criteria:

  • History of 2 doses of varicella vaccination;
  • Previous history of varicella or herpes zoster (not applicable to investigation ofvaricella antibody level);
  • History of severe allergic reactions to vaccines (e.g.acute anaphylaxis, angioneuroticedema, dyspnea, etc.);
  • Suffering from acute disease or acute episode of chronic disease;
  • Any confirmed or suspected immunodeficiency disease, including human immunodeficiencyvirus (HIV) infection;
  • Axillary temperature >37.0°C;
  • Receipt of other investigational drugs in the past 30 days;
  • Receipt of attenuated live vaccines in the past 28 days;
  • Receipt of inactivated or subunit vaccines in the past 7 days;
  • 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: 37920
Study Start date:
July 30, 2022
Estimated Completion Date:
May 15, 2023

Study Description

This study is Phase Ⅳ clinical trial.The experimental vaccine manufactured by Sinovac(Dalian) Vaccine Technology Co., Ltd.This clinical trial consists of five parts,and A total of 37920 subjects will be enrolled.

Study 1,360 subjects including 120 subjects aged 1-3 years with no history of varicella vaccination ,240 subjects aged 4-6 years with a history of 1 dose of varicella vaccine will be enrolled to evaluate the immunogenicity and safety of varicella vaccine.All subjects will receive one dose of varicella vaccine.

Study 2,2530 subjects aged 0-59 years old will be enrolled and will be collected venous blood to detect varicella antibody and conduct investigation of varicella antibody level in healthy people.

Study 3,30000 subjects aged 1-12 years old will be enrolled to conduct safety observation study.All subjects will receive one dose of varicella vaccine and all adverse events of all subjects will be collected.

Study 4,5000 subjects aged 1-12 years old will be enrolled to conduct protective effect study of varicella vaccine after exposure.

Study 5,30 subjects aged 1-12 years old will be enrolled. Herpes fluid or pharyngeal swab samples of subjects will be collected to study the pathogenicity of varicella.

Connect with a study center

  • Laian Center for Disease Control and Prevention

    Chuzhou, Anhui 239299
    China

    Active - Recruiting

  • Liandu District Center for Disease Control and Prevention

    Lishui, Zhejiang 323050
    China

    Active - Recruiting

  • Jiangshan Center for Disease Control and Prevention

    Quzhou, Zhejiang 324199
    China

    Active - Recruiting

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