Clinical trial NCT06208683: The Immunogenicity and Safety of the Booster Doses of a Live-attenuated Mumps Vaccine in Junior High School Students
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Mumps
Influenza
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-01-17
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Geometric mean concentrations (GMCs) of mumps antibody
timeFrame: 30 days after the vaccination of MV
Secondary outcomes:
measure: Geometric mean increases (GMIs) of mumps antibody
timeFrame: 30 days after the vaccination of MV
measure: Seroconversion rate of mumps antibody
timeFrame: 30 days after the vaccination of MV
measure: Seropositivity rate of mumps antibody
timeFrame: 30 days after the vaccination of MV
measure: Geometric mean titers (GMTs) of influenza antibody
timeFrame: 30 days after the vaccination of QIV
measure: Geometric mean increases (GMIs) of influenza antibody
timeFrame: 30 days after the vaccination of QIV
measure: Seroconversion rate of influenza antibody
timeFrame: 30 days after the vaccination of QIV
measure: Seropositivity rate of influenza antibody
timeFrame: 30 days after the vaccination of QIV
measure: Geometric mean concentrations (GMCs) of mumps antibody 30 days after the simultaneous vaccination of MV and QIV
timeFrame: 30 days after the simultaneous vaccination of MV and QIV
measure: Geometric mean titers (GMTs) of influenza antibody 30 days after the simultaneous vaccination of MV and QIV
timeFrame: 30 days after the simultaneous vaccination of MV and QIV
measure: Geometric mean increases (GMIs) of mumps antibody and influenza antibody
timeFrame: 30 days after the simultaneous vaccination of MV and QIV
measure: Seroconversion rate of mumps antibody and influenza antibody
timeFrame: 30 days after the simultaneous vaccination of MV and QIV
measure: Seropositivity rate of mumps antibody and influenza antibody
timeFrame: 30 days after the simultaneous vaccination of MV and QIV
measure: The incidence of adverse reactions 0-7 days after vaccination
timeFrame: 0-7 days after vaccination
measure: The incidence of adverse reactions 0-14 days after vaccination
timeFrame: 0-14 days after vaccination
measure: The incidence of adverse reactions 0-30 days after vaccination
timeFrame: 0-30 days after vaccination
measure: Geometric mean concentrations (GMCs) of measles antibody before vaccination
timeFrame: before vaccination
measure: Geometric mean concentrations (GMCs) of rubella antibody before vaccination
timeFrame: before vaccination
measure: Geometric mean titers (GMTs) of varicella-zostor antibody before vaccination
timeFrame: before vaccination
measure: Geometric mean concentrations (GMCs) of mumps antibody before vaccination
timeFrame: before vaccination
measure: Geometric mean titers (GMTs) of influenza antibody before vaccination
timeFrame: before vaccination
measure: Seropositivity rate of measles antibody before vaccination
timeFrame: before vaccination
measure: Seropositivity rate of rubella antibody before vaccination
timeFrame: before vaccination
measure: Seropositivity rate of varicella-zostor antibody before vaccination
timeFrame: before vaccination
measure: Seropositivity rate of mumps antibody before vaccination
timeFrame: before vaccination
measure: Seropositivity rate of influenza antibody before vaccination
timeFrame: before vaccination
measure: Cross-neutralizing antibody titer of mumps vaccine
timeFrame: 30 days after the vaccination of MV alone or simultaneously with QIV
Other outcomes:
Locations:
city: Xianyang
country: China
facility: Qindu Distric Center for Disease Prevention and Control
state: Shaanxi
city: Xianyang
country: China
facility: Xingping Center for Disease Prevention and Control
state: Shaanxi
city: Yulin
country: China
facility: Yuyang Distict Center for Disease Prevention and Control
state: Shaanxi
Study officials:
affiliation: Shaanxi Provincial Center for Disease Prevention and Control
name: Weijun Hu, Master
role: PRINCIPAL_INVESTIGATOR
References: