Last updated: December 24, 2023
Sponsor: Shanghai Institute Of Biological Products
Overall Status: Completed
Phase
3
Condition
Herpes Simplex Infections
Chickenpox (Varicella Zoster Infection)
Throat And Tonsil Infections
Treatment
Live attenuated varicella vaccines manufactured by Shanghai Institute of Biological Products Co.,Ltd.
Live attenuated varicella vaccines manufactured by Changchun BCHT Biotechnology Co.,Ltd
Clinical Study ID
NCT05158777
2020LP00094-III
Ages > 13 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Healthy population aged 13 years and above;
- Proven legal identity;
- The subjects and/or guardians can understand and voluntarily sign the informed consentform (For subjects aged 13-17 years, both subjects and guardians need to sign theinformed consent form).
Exclusion
Exclusion Criteria:
- Disease history or vaccine history of chickenpox or shingles;
- 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 vaccinecomponents, or serious adverse reactions to the vaccine, such as urticaria, dyspnea,angioedema and abdominal pain;
- Congenital malformations or developmental disorders, genetic defects, severemalnutrition, etc.;
- Autoimmune disease or immunodeficiency / immunosuppression;
- Severe chronic diseases, severe cardiovascular diseases, hypertension (adult fieldmeasurement: SBP ≥140mmHg or diastolic blood pressure ≥90mmHg) that could not becontrolled by drugs, diabetes, liver and kidney diseases, malignant tumors, etc.;
- Family history of psychosis,severe neurological disease (epilepsy, convulsions ortwitching) or mental illness;
- Thyroid disease or history of thyroidectomy, asplenia, functional asplenia, aspleniaor 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 (excludingallergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitissuperficial 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 arenot suitable for participating in the clinical trial.
Study Design
Total Participants: 2480
Treatment Group(s): 2
Primary Treatment: Live attenuated varicella vaccines manufactured by Shanghai Institute of Biological Products Co.,Ltd.
Phase: 3
Study Start date:
February 13, 2022
Estimated Completion Date:
November 14, 2022
Study Description
Connect with a study center
Henan Provincial Center for Disease Prevention and Control
Zhenzhou, Henan
ChinaSite Not Available

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