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/AClinical Study ID
NCT05460429
PRO-VAR-MA4002-ZJ
Ages < 59 All Genders Accepts Healthy Volunteers
Study Summary
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
Connect with a study center
Laian Center for Disease Control and Prevention
Chuzhou, Anhui 239299
ChinaActive - Recruiting
Liandu District Center for Disease Control and Prevention
Lishui, Zhejiang 323050
ChinaActive - Recruiting
Jiangshan Center for Disease Control and Prevention
Quzhou, Zhejiang 324199
ChinaActive - Recruiting
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