Status:
UNKNOWN
The Immunogenicity and Safety of the Booster Doses of a Live-attenuated Mumps Vaccine in Junior High School Students
Lead Sponsor:
Sinovac Biotech Co., Ltd
Conditions:
Mumps
Influenza
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
This study is a randomized, controlled, open-label phase Ⅳ clinical trial of a live attenuated mumps vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The purpose of this study is ...
Detailed Description
This study is an open-lable, randomised, controlled phase Ⅳ clinical trial in healthy junior high school students to the immunogenicity and safety of the booster doses of a mumps vaccine (MV) administ...
Eligibility Criteria
Inclusion
- Healthy junior high school students;
- subjects and/or guardians who can understand and voluntarily sign the informed consent form (For subjects aged 8-17 years, both subjects and guardians need to sign the informed consent form)
- Provision of valid identification.;
- History of 1 or 2 doses of mumps-containing vaccine;
Exclusion
- History of mumps or have completed 3 doses of mumps-containing vaccine;
- Receipt of the current seasonal influenza vaccine (except subjects in Arm 4)
- History of asthma or 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;
- Autoimmune disease (such as systemic lupus erythematosus) or a state of immunodeficiency / immunosuppression (such as AIDS, after organ transplantation);
- Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc.;
- Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
- Thyroid disease or history of thyroidectomy, asplenia, functional asplenia, any condition resulting in asplenia or splenectomy;
- Abnormal coagulation function diagnosed by a doctor (such as coagulation factor deficiency, coagulation disease, platelet abnormality) or obvious bruising or coagulation disorder;
- Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis, topical corticosteroid therapy for acute uncomplicated dermatitis) within the past 6 months;
- Receipt of blood products in the past 3 months;
- 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;
- Onset of various acute or chronic diseases within 7 days prior to the study;
- Axillary temperature \>37.0°C;
- Participation in other clinical trials before enrollment and during the follow-up period, or a plan to participate in other clinical trials within 3 months.
- Any other factors that are unsuitable for participating in this clinical trial according to the investigator's judgment
Key Trial Info
Start Date :
November 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06208683
Start Date
November 4 2023
End Date
December 1 2024
Last Update
January 17 2024
Active Locations (3)
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1
Qindu Distric Center for Disease Prevention and Control
Xianyang, Shaanxi, China, 712099
2
Xingping Center for Disease Prevention and Control
Xianyang, Shaanxi, China, 713199
3
Yuyang Distict Center for Disease Prevention and Control
Yulin, Shaanxi, China, 719054