the immunogenicity and safety of the booster doses of a live-attenuated mumps vaccine in junior high school students

Conditions: Mumps; Influenza

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 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

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) administrated alone and concomitantly with a quadrivalent influenza vaccine (qiv) in healthy junior high school students. the experimental vaccine was manufactured by sinovac (dalian) vaccine technology co., ltd. a total of 400 healthy students will be enrolled, including 300 students who have received one dose of mumps-containing vaccine (mcv) before vaccination, and 100 students who have received two doses of mumps-containing vaccine before vaccination. 300 students with a history of 1 dose of mcv will be randomly divided into 3 groups in a ratio of 1:1:1, and will receive 1 dose of mv alone, 1 dose of qiv alone, or 1 dose of mv and 1 dose of qiv simultaneously. students with a history of 2 doses of mcv received 1 dose of mv alone. blood samples were collected before and 30 days after vaccination. pre-vaccination blood samples were used to detect antibody levels of measles, mumps, influenza and varicella, and post-vaccination blood samples were used to detect mumps antibodies and/or influenza antibodies corresponding to the vaccination.

Eligibility criteria:
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