The Immunogenicity and Safety of the Booster Doses of a Live-attenuated Mumps Vaccine in Junior High School Students
1 other identifier
interventional
400
1 country
3
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2023
Shorter than P25 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 4, 2023
CompletedFirst Submitted
Initial submission to the registry
November 23, 2023
CompletedFirst Posted
Study publicly available on registry
January 17, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedJanuary 17, 2024
November 1, 2023
3 months
November 23, 2023
January 5, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Geometric mean concentrations (GMCs) of mumps antibody
GMC s of mumps antibody 30 days after the vaccination of MV
30 days after the vaccination of MV
Secondary Outcomes (26)
Geometric mean increases (GMIs) of mumps antibody
30 days after the vaccination of MV
Seroconversion rate of mumps antibody
30 days after the vaccination of MV
Seropositivity rate of mumps antibody
30 days after the vaccination of MV
Geometric mean titers (GMTs) of influenza antibody
30 days after the vaccination of QIV
Geometric mean increases (GMIs) of influenza antibody
30 days after the vaccination of QIV
- +21 more secondary outcomes
Study Arms (4)
1MCV: MV
EXPERIMENTAL100 students with a history of 1 dose of MCV will receive 1 dose of MV.
1MCV: QIV
EXPERIMENTAL100 students with a history of 1 dose of MCV will receive 1 dose of QIV.
1MCV: MV +QIV
EXPERIMENTAL100 students with a history of 1 dose of MCV will receive 1 dose of MV and 1 dose of QIV simultaneously.
2MCV: MV
EXPERIMENTAL100 students with a history of 2 dose of MCV will receive 1 dose of MV.
Interventions
0.5mL per dose,containing ≥3.7 lg CCID50 live mumps virus
0.5mL per dose, containing 4 strains of influenza virus recommended by the WHO, 15ug of each strain.
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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;
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Qindu Distric Center for Disease Prevention and Control
Xianyang, Shaanxi, 712099, China
Xingping Center for Disease Prevention and Control
Xianyang, Shaanxi, 713199, China
Yuyang Distict Center for Disease Prevention and Control
Yulin, Shaanxi, 719054, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Weijun Hu, Master
Shaanxi Provincial Center for Disease Prevention and Control
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2023
First Posted
January 17, 2024
Study Start
November 4, 2023
Primary Completion
February 2, 2024
Study Completion
December 1, 2024
Last Updated
January 17, 2024
Record last verified: 2023-11