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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
This study is an open-lable, randomised, controlled phase â…£ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1MCV: MV | Experimental | 100 students with a history of 1 dose of MCV will receive 1 dose of MV. |
|
| 1MCV: QIV | Experimental | 100 students with a history of 1 dose of MCV will receive 1 dose of QIV. |
|
| 1MCV: MV +QIV | Experimental | 100 students with a history of 1 dose of MCV will receive 1 dose of MV and 1 dose of QIV simultaneously. |
|
| 2MCV: MV | Experimental | 100 students with a history of 2 dose of MCV will receive 1 dose of MV. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mumps vaccine, Live (MV) | Biological | 0.5mL per dose,containing ≥3.7 lg CCID50 live mumps virus |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean increases (GMIs) of mumps antibody | Geometric mean increases (GMIs) of mumps antibody 30 days after the vaccination of MV | 30 days after the vaccination of MV |
| Seroconversion rate of mumps antibody |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Weijun Hu, Master | Shaanxi Provincial Center for Disease Prevention and Control | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qindu Distric Center for Disease Prevention and Control | Xianyang | Shaanxi | 712099 | China | ||
| Xingping Center for Disease Prevention and Control |
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| Influenza Vaccine, inactivated, quadrivlent(QIV) | Biological | 0.5mL per dose, containing 4 strains of influenza virus recommended by the WHO, 15ug of each strain. |
|
Seroconversion rate of mumps antibody 30 days after the vaccination of MV
| 30 days after the vaccination of MV |
| Seropositivity rate of mumps antibody | Seropositivity rate of mumps antibody 30 days after the vaccination of MV | 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 | 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 | 30 days after the vaccination of QIV |
| Seroconversion rate of influenza antibody | Seroconversion rate of influenza antibody 30 days after the vaccination of QIV | 30 days after the vaccination of QIV |
| Seropositivity rate of influenza antibody | Seropositivity rate of influenza antibody 30 days after the vaccination of QIV | 30 days after the vaccination of QIV |
| Geometric mean concentrations (GMCs) of mumps antibody 30 days after the simultaneous vaccination of MV and QIV | Geometric mean concentrations (GMCs) of mumps antibody | 30 days after the simultaneous vaccination of MV and QIV |
| Geometric mean titers (GMTs) of influenza antibody 30 days after the simultaneous vaccination of MV and QIV | Geometric mean titers (GMTs) of influenza antibody | 30 days after the simultaneous vaccination of MV and QIV |
| Geometric mean increases (GMIs) of mumps antibody and influenza antibody | Geometric mean increases (GMIs) of mumps antibody and influenza antibody 30 days after the simultaneous vaccination of MV and QIV | 30 days after the simultaneous vaccination of MV and QIV |
| Seroconversion rate of mumps antibody and influenza antibody | Seroconversion rate of mumps antibody and influenza antibody 30 days after the simultaneous vaccination of MV and QIV | 30 days after the simultaneous vaccination of MV and QIV |
| Seropositivity rate of mumps antibody and influenza antibody | Seropositivity rate of mumps antibody and influenza antibody 30 days after the simultaneous vaccination of MV and QIV | 30 days after the simultaneous vaccination of MV and QIV |
| The incidence of adverse reactions 0-7 days after vaccination | The incidence of adverse reactions 0-7 days after vaccination | 0-7 days after vaccination |
| The incidence of adverse reactions 0-14 days after vaccination | The incidence of adverse reactions 0-14 days after vaccination | 0-14 days after vaccination |
| The incidence of adverse reactions 0-30 days after vaccination | The incidence of adverse reactions 0-30 days after vaccination | 0-30 days after vaccination |
| Geometric mean concentrations (GMCs) of measles antibody before vaccination | Geometric mean concentrations (GMCs) of measles antibody before vaccination | before vaccination |
| Geometric mean concentrations (GMCs) of rubella antibody before vaccination | Geometric mean concentrations (GMCs) of rubella antibody before vaccination | before vaccination |
| Geometric mean titers (GMTs) of varicella-zostor antibody before vaccination | Geometric mean titers (GMTs) of varicella-zostor antibody before vaccination | before vaccination |
| Geometric mean concentrations (GMCs) of mumps antibody before vaccination | Geometric mean concentrations (GMCs) of mumps antibody before vaccination | before vaccination |
| Geometric mean titers (GMTs) of influenza antibody before vaccination | Geometric mean titers (GMTs) of influenza antibody before vaccination | before vaccination |
| Seropositivity rate of measles antibody before vaccination | Seropositivity rate of measles antibody before vaccination | before vaccination |
| Seropositivity rate of rubella antibody before vaccination | Seropositivity rate of rubella antibody before vaccination | before vaccination |
| Seropositivity rate of varicella-zostor antibody before vaccination | Seropositivity rate of varicella-zostor antibody before vaccination | before vaccination |
| Seropositivity rate of mumps antibody before vaccination | Seropositivity rate of mumps antibody before vaccination | before vaccination |
| Seropositivity rate of influenza antibody before vaccination | Seropositivity rate of influenza antibody before vaccination | before vaccination |
| Cross-neutralizing antibody titer of mumps vaccine | Cross-neutralizing antibody titer of mumps vaccine against different genotypes of mumps virus | 30 days after the vaccination of MV alone or simultaneously with QIV |
| Xianyang |
| Shaanxi |
| 713199 |
| China |
| Yuyang Distict Center for Disease Prevention and Control | Yulin | Shaanxi | 719054 | China |
| ID | Term |
|---|---|
| D009107 | Mumps |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D019351 | Rubulavirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D010309 | Parotitis |
| D010305 | Parotid Diseases |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D012141 | Respiratory Tract Infections |
| D009976 | Orthomyxoviridae Infections |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D009108 | Mumps Vaccine |
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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