The Immunogenicity and Safety of the Booster Doses of a Live-attenuated Mumps Vaccine in Junior H… (NCT06208683) | Clinical Trial Compass
UnknownPhase 4
The Immunogenicity and Safety of the Booster Doses of a Live-attenuated Mumps Vaccine in Junior High School Students
China400 participantsStarted 2023-11-04
Plain-language summary
This study is a randomized, controlled, open-label phase â…£ 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
Who can participate
SexALL
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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;
* …
What they're measuring
1
Geometric mean concentrations (GMCs) of mumps antibody