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
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- Geometric mean concentrations (GMCs) of mumps antibody
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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;
排除标准
- •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
结局指标
主要结局
Geometric mean concentrations (GMCs) of mumps antibody
时间窗: 30 days after the vaccination of MV
GMC s of mumps antibody 30 days after the vaccination of MV
次要结局
- Geometric mean titers (GMTs) of influenza antibody(30 days after the vaccination of QIV)
- Seropositivity rate of influenza antibody(30 days after the vaccination of QIV)
- Geometric mean concentrations (GMCs) of mumps antibody 30 days after the simultaneous vaccination of MV and QIV(30 days after the simultaneous vaccination of MV and QIV)
- Geometric mean titers (GMTs) of influenza antibody 30 days after the simultaneous vaccination of MV and QIV(30 days after the simultaneous vaccination of MV and QIV)
- Seropositivity rate of influenza antibody before vaccination(before vaccination)
- Geometric mean increases (GMIs) of mumps antibody(30 days after the vaccination of MV)
- Geometric mean increases (GMIs) of influenza antibody(30 days after the vaccination of QIV)
- Geometric mean increases (GMIs) of mumps antibody and influenza antibody(30 days after the simultaneous vaccination of MV and QIV)
- Geometric mean concentrations (GMCs) of mumps antibody before vaccination(before vaccination)
- Seroconversion rate of mumps antibody(30 days after the vaccination of MV)
- The incidence of adverse reactions 0-7 days after vaccination(0-7 days after vaccination)
- The incidence of adverse reactions 0-30 days after vaccination(0-30 days after vaccination)
- Geometric mean concentrations (GMCs) of measles antibody before vaccination(before vaccination)
- Geometric mean titers (GMTs) of varicella-zostor antibody before vaccination(before vaccination)
- Seropositivity rate of rubella antibody before vaccination(before vaccination)
- Seropositivity rate of mumps antibody before vaccination(before vaccination)
- Seropositivity rate of mumps antibody(30 days after the vaccination of MV)
- Seroconversion rate of influenza antibody(30 days after the vaccination of QIV)
- Geometric mean concentrations (GMCs) of rubella antibody before vaccination(before vaccination)
- Geometric mean titers (GMTs) of influenza antibody before vaccination(before vaccination)
- Seropositivity rate of measles antibody before vaccination(before vaccination)
- Seropositivity rate of mumps antibody and influenza antibody(30 days after the simultaneous vaccination of MV and QIV)
- The incidence of adverse reactions 0-14 days after vaccination(0-14 days after vaccination)
- Cross-neutralizing antibody titer of mumps vaccine(30 days after the vaccination of MV alone or simultaneously with QIV)
- Seroconversion rate of mumps antibody and influenza antibody(30 days after the simultaneous vaccination of MV and QIV)
- Seropositivity rate of varicella-zostor antibody before vaccination(before vaccination)