The Immunogenicity and Safety of the Booster Doses of a Live-attenuated Mumps Vaccine in Junior High School Students
- Conditions
- MumpsInfluenza
- Interventions
- Biological: Mumps vaccine, Live (MV)Biological: Influenza Vaccine, inactivated, quadrivlent(QIV)
- Registration Number
- NCT06208683
- Lead Sponsor
- Sinovac Biotech Co., Ltd
- 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 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
- 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) 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 400
- 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;
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1MCV: MV +QIV Mumps vaccine, Live (MV) 100 students with a history of 1 dose of MCV will receive 1 dose of MV and 1 dose of QIV simultaneously. 2MCV: MV Mumps vaccine, Live (MV) 100 students with a history of 2 dose of MCV will receive 1 dose of MV. 1MCV: MV Mumps vaccine, Live (MV) 100 students with a history of 1 dose of MCV will receive 1 dose of MV. 1MCV: QIV Influenza Vaccine, inactivated, quadrivlent(QIV) 100 students with a history of 1 dose of MCV will receive 1 dose of QIV. 1MCV: MV +QIV Influenza Vaccine, inactivated, quadrivlent(QIV) 100 students with a history of 1 dose of MCV will receive 1 dose of MV and 1 dose of QIV simultaneously.
- Primary Outcome Measures
Name Time Method Geometric mean concentrations (GMCs) of mumps antibody 30 days after the vaccination of MV GMC s of mumps antibody 30 days after the vaccination of MV
- Secondary Outcome Measures
Name Time Method Geometric mean titers (GMTs) of influenza antibody 30 days after the vaccination of QIV 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 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 concentrations (GMCs) of mumps antibody
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 Geometric mean titers (GMTs) of influenza antibody
Geometric mean increases (GMIs) of mumps antibody 30 days after the vaccination of MV 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 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 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 Geometric mean concentrations (GMCs) of mumps antibody before vaccination
Seropositivity rate of influenza antibody before vaccination before vaccination Seropositivity rate of influenza antibody before vaccination
Seroconversion rate of mumps antibody 30 days after the vaccination of MV 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 0-7 days after vaccination
The incidence of adverse reactions 0-30 days after vaccination 0-30 days after vaccination The incidence of adverse reactions 0-30 days after vaccination
Geometric mean concentrations (GMCs) of measles antibody before vaccination before vaccination Geometric mean concentrations (GMCs) of measles antibody before vaccination
Geometric mean titers (GMTs) of varicella-zostor antibody before vaccination before vaccination Geometric mean titers (GMTs) of varicella-zostor antibody before vaccination
Seropositivity rate of rubella antibody before vaccination before vaccination Seropositivity rate of rubella antibody before vaccination
Seropositivity rate of mumps antibody before vaccination before vaccination Seropositivity rate of mumps antibody before vaccination
Seropositivity rate of mumps antibody 30 days after the vaccination of MV Seropositivity rate of mumps antibody 30 days after the vaccination of MV
Seroconversion rate of influenza antibody 30 days after the vaccination of QIV 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 concentrations (GMCs) of rubella antibody before vaccination
Geometric mean titers (GMTs) of influenza antibody before vaccination before vaccination Geometric mean titers (GMTs) of influenza antibody before vaccination
Seropositivity rate of measles antibody before vaccination before vaccination Seropositivity rate of measles antibody before vaccination
Seropositivity rate of mumps antibody and influenza antibody 30 days after the simultaneous vaccination of MV and QIV 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 The incidence of adverse reactions 0-14 days after vaccination
Cross-neutralizing antibody titer of mumps vaccine 30 days after the vaccination of MV alone or simultaneously with QIV Cross-neutralizing antibody titer of mumps vaccine against different genotypes of mumps virus
Seroconversion rate of mumps antibody and influenza antibody 30 days after the simultaneous vaccination of MV and 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 Seropositivity rate of varicella-zostor antibody before vaccination
Trial Locations
- Locations (3)
Qindu Distric Center for Disease Prevention and Control
🇨🇳Xianyang, Shaanxi, China
Xingping Center for Disease Prevention and Control
🇨🇳Xianyang, Shaanxi, China
Yuyang Distict Center for Disease Prevention and Control
🇨🇳Yulin, Shaanxi, China