Influenza, Mumps
Conditions
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.
Interventions
BIOLOGICALMumps vaccine, Live (MV)
0.5mL per dose,containing ≥3.7 lg CCID50 live mumps virus
BIOLOGICALInfluenza Vaccine, inactivated, quadrivlent(QIV)
0.5mL per dose, containing 4 strains of influenza virus recommended by the WHO, 15ug of each strain.
Sponsors
Sinovac Biotech Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Seroconversion rate 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 | 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 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 | Geometric mean increases (GMIs) of influenza antibody 30 days after the vaccination of QIV |
| Seroconversion rate of influenza antibody | 30 days after the vaccination of QIV | Seroconversion rate 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 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 |
| 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 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 0-7 days after vaccination | 0-7 days after vaccination | The incidence of adverse reactions 0-7 days after vaccination |
| 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 |
| 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 concentrations (GMCs) of rubella antibody before vaccination | before vaccination | Geometric mean concentrations (GMCs) of rubella 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 |
| Geometric mean concentrations (GMCs) of mumps antibody before vaccination | before vaccination | Geometric mean concentrations (GMCs) of mumps 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 rubella antibody before vaccination | before vaccination | Seropositivity rate of rubella antibody before vaccination |
| Seropositivity rate of varicella-zostor antibody before vaccination | before vaccination | Seropositivity rate of varicella-zostor antibody before vaccination |
| Seropositivity rate of mumps antibody before vaccination | before vaccination | Seropositivity rate of mumps antibody before vaccination |
| Seropositivity rate of influenza antibody before vaccination | before vaccination | Seropositivity rate of influenza antibody before 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 |
| 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 |
Countries
China
Outcome results
None listed