The Immunogenicity and Safety of the Booster Doses of a Live-attenuated Mumps Vaccine Administrated Alone and Concomitantly With a Quadrivalent Inactivated Influenza Vaccine in Junior High School Students

PRO-MUM-MA4001-SN

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 to evaluate the immunogenicity and safety of the booster doses of a mumps vaccine administrated alone and concomitantly with a quadrivalent inactivated influenza vaccine in healthy junior high school students. And the cross-neutralization of mumps vaccine immune serum and mumps virus strains

2023-11-04

2024-02-02

2024-12-01

Active (not recruiting)

Early phase I

400

Inclusion Criteria: * 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 Criteria: * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 400, 'type': 'ACTUAL'}}

2024-01-17