Safety and Immunogenicity of Live Attenuated Varicella Vaccine in Healthy Population Aged ≥13 Years Old
NCT ID: NCT05158777
Last Updated: 2023-12-29
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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COMPLETED
PHASE3
2480 participants
INTERVENTIONAL
2022-02-13
2022-11-14
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 or 0,56 days
1240 subjects (including 620 children aged 13-17 years and 620 adults aged 18 years and older) will receive two doses of experimental vaccine with the immunization course of 0,28 days or 0,56 days.
Live attenuated varicella vaccines manufactured by Shanghai Institute of Biological Products Co.,Ltd.
live varicella-zoster virus in 0.5 mL of sucrose, sodium chloride, potassium chloride, sodium glutamate, phosphate and injection water per injection
Control Group
1240 subjects (including 620 children aged 13-17 years and 620 adults aged 18 years and older) will receive two doses of control vaccine with the immunization course of 0,28 days or 0,56 days.
Live attenuated varicella vaccines manufactured by Changchun BCHT Biotechnology Co.,Ltd
live varicella-zoster virus in 0.5 mL of mannitol, dextrose tincture, sucrose, trehalose, human serum albumin and injection water per injection
Interventions
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Live attenuated varicella vaccines manufactured by Shanghai Institute of Biological Products Co.,Ltd.
live varicella-zoster virus in 0.5 mL of sucrose, sodium chloride, potassium chloride, sodium glutamate, phosphate and injection water per injection
Live attenuated varicella vaccines manufactured by Changchun BCHT Biotechnology Co.,Ltd
live varicella-zoster virus in 0.5 mL of mannitol, dextrose tincture, sucrose, trehalose, human serum albumin and injection water per injection
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
* Have fever before vaccination, 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 severe allergy and asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioedema and abdominal pain;
* 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) that could not be controlled by drugs, diabetes, liver and kidney diseases, malignant tumors, etc.;
* Family history of psychosis,severe neurological disease (epilepsy, convulsions or twitching) 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 6 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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Shanghai Institute Of Biological Products
INDUSTRY
Responsible Party
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Principal Investigators
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Yanxia Wang
Role: PRINCIPAL_INVESTIGATOR
Henan Provincial Center for Disease Control and Prevention
Locations
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Henan Provincial Center for Disease Prevention and Control
Zhenzhou, Henan, China
Countries
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Other Identifiers
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2020LP00094-III
Identifier Type: -
Identifier Source: org_study_id