The Immunogenicity and Safety of the Booster Doses of a Live-attenuated Mumps Vaccine in Junior High School Students

Phase 4UnknownNCT06208683

Sinovac Biotech Co., Ltd400 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

400

Conditions

Mumps Influenza

Interventions

Mumps vaccine, Live (MV)BIOLOGICAL

0.5mL per dose,containing ≥3.7 lg CCID50 live mumps virus

Influenza Vaccine, inactivated, quadrivlent(QIV)BIOLOGICAL

0.5mL per dose, containing 4 strains of influenza virus recommended by the WHO, 15ug of each strain.

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Geometric mean concentrations (GMCs) of mumps antibody

GMC s of mumps antibody 30 days after the vaccination of MV

Time frame: 30 days after the vaccination of MV

Secondary Outcomes

Geometric mean increases (GMIs) of mumps antibody

Geometric mean increases (GMIs) of mumps antibody 30 days after the vaccination of MV

Time frame: 30 days after the vaccination of MV

Seroconversion rate of mumps antibody

Seroconversion rate of mumps antibody 30 days after the vaccination of MV

Time frame: 30 days after the vaccination of MV

Seropositivity rate of mumps antibody

Seropositivity rate of mumps antibody 30 days after the vaccination of MV

Time frame: 30 days after the vaccination of MV

Geometric mean titers (GMTs) of influenza antibody

Geometric mean titers (GMTs) of influenza antibody 30 days after the vaccination of QIV

Time frame: 30 days after the vaccination of QIV

Geometric mean increases (GMIs) of influenza antibody

Geometric mean increases (GMIs) of influenza antibody 30 days after the vaccination of QIV

Time frame: 30 days after the vaccination of QIV

Seroconversion rate of influenza antibody

Seroconversion rate of influenza antibody 30 days after the vaccination of QIV

Time frame: 30 days after the vaccination of QIV

Data from ClinicalTrials.gov

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