Safety and Immunogenicity of Live Attenuated Varicella Vaccine in Healthy Population Aged ≥13 Years Old
NCT ID: NCT05015686
Last Updated: 2024-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
PHASE3
2400 participants
INTERVENTIONAL
2021-09-30
2026-09-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Experimental Group with the immunization course of 0,28 days, 0,42 days or 0,56 days
960 subjects (including 480 children aged 13-17 years and 480 adults aged 18 years and older) will receive two doses of experimental vaccine with the immunization course of 0,28 days, 0,42 days or 0,56 days.
Live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd
live varicella-zoster virus in 0·5 mL of sucrose, sodium glutamate,sodium chloride,potassium chloride,sodium dihydrogen phosphate, potassium dihydrogen phosphate and injection water per injection
Control Group
960 subjects (including 480 children aged 13-17 years and 480 adults aged 18 years and older) will receive two doses of control vaccine with the immunization course of 0,28 days, 0,42 days or 0,56 days.
Live attenuated varicella vaccines manufactured by Changchun BCHT Biotechnology Co.,Ltd
live varicella-zoster virus in trehalose,human serum albumin,sodium glutamate,sucrose,glucose,carbamide,arginine and injection water per injection
Experimental Group with the immunization course of 0, 70 days
320 subjects (including 160 children aged 13-17 years and 160 adults aged 18 years and older) will receive two doses of the experimental vaccine with the immunization course of 0, 70 days.
Live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd
live varicella-zoster virus in 0·5 mL of sucrose, sodium glutamate,sodium chloride,potassium chloride,sodium dihydrogen phosphate, potassium dihydrogen phosphate and injection water per injection
Placebo group
160 subjects (including 80children aged 13-17 years and 80 adults aged 18 years and older) will receive two doses of the placebo with the immunization course of 0, 70 days.
Placebo
Sodium chloride and distilled water
Interventions
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Live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd
live varicella-zoster virus in 0·5 mL of sucrose, sodium glutamate,sodium chloride,potassium chloride,sodium dihydrogen phosphate, potassium dihydrogen phosphate and injection water per injection
Live attenuated varicella vaccines manufactured by Changchun BCHT Biotechnology Co.,Ltd
live varicella-zoster virus in trehalose,human serum albumin,sodium glutamate,sucrose,glucose,carbamide,arginine and injection water per injection
Live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd
live varicella-zoster virus in 0·5 mL of sucrose, sodium glutamate,sodium chloride,potassium chloride,sodium dihydrogen phosphate, potassium dihydrogen phosphate and injection water per injection
Placebo
Sodium chloride and distilled water
Eligibility Criteria
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Inclusion Criteria
* Proven legal identity;
* The subjects and/or guardians can understand and voluntarily sign the informed consent form (For subjects aged 13-17 years, both subjects and guardians need to sign the informed consent form);
Exclusion Criteria
* Axillary temperature \>37.0°C;
* Already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to get pregnant within 6 months;
* History of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema;
* Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc;
* Autoimmune disease or immunodeficiency / immunosuppression;
* Severe chronic diseases, severe cardiovascular diseases,hypertension(adult field measurement: SBP ≥140mmHg or diastolic blood pressure ≥90mmHg)and diabetes that cannot be controlled by drugs, liver or kidney diseases;
* Family history of psychosis,severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
* Thyroid disease or history of thyroidectomy, asplenia, functional asplenia,asplenia or splenectomy resulting from any condition;
* Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
* Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
* History of alcohol or drug abuse;
* Receipt of blood products within in the past 3 months;
* Participating in other drug/vaccine clinical trial;
* Receipt of attenuated live vaccines in the past 28 days;
* Receipt of inactivated or subunit vaccines in the past 7 days;
* Onset of various acute or chronic diseases within 7 days prior to the study;
* According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
13 Years
ALL
Yes
Sponsors
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Sinovac (Dalian) Vaccine Technology Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Lili Huang, Bachelor
Role: PRINCIPAL_INVESTIGATOR
Henan Provincial Center for Disease Prevention and Control
Locations
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Yucheng Center for Disease Control and Prevention
Shangqiu, Henan, China
Countries
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Other Identifiers
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PRO-VZV-4002
Identifier Type: -
Identifier Source: org_study_id
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