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The purpose of this study is to evaluate the safety and immunogenicity of mumps vaccine in healthy infants aged 8-12months, compared with measles, mumps and rubella combined vaccine, live (MMRV).
The study is a randomized, double-blind, controlled phase â…£ clinical trial. And 920 infants will be assigned to investigational group and controlled group in a 1:1 ratio. The investigational vaccine is manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The controlled vaccine is manufactured by Shanghai institute of biological products Co., Ltd.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Mumps vaccine, one dose |
|
| Control group | Active Comparator | measles, mumps and rubella combined vaccine, live, one dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mumps vaccine | Biological | One dose of mumps vaccine: 0.5 ml per dose, mumps live virus not less than 3.7 lg CCID50 |
|
| Measure | Description | Time Frame |
|---|---|---|
| The seroconversion rate of hemagglutination inhibition (HI) antibody | Immunogenicity index, One of the standard to evaluate the immunogenicity of experimental vaccine | the 30th day after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| The GMT of HI antibody | Immunogenicity index, Another standard to evaluate the immunogenicity of experimental vaccine | the 30th day after vaccination |
| The incidence of the solicited local and systemic adverse reactions |
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Inclusion Criteria:
Exclusion Criteria:
Received mumps vaccine or vaccine containing mumps virus;
History of mumps;
Axillary temperature > 37.4 °C;
History of allergy to any vaccine or vaccine ingredient;
History of serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc;
Autoimmune disease or immunodeficiency or immunosuppression;
Congenital malformation, genetic defects, severe malnutrition;
Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders;
Severe chronic diseases (e.g., severe cardiovascular disease, liver and kidney disease beyond the control of drugs, or cancer)
Severe neurological disorders (epilepsy, seizures or convulsions) or psychosis;
History of thyroidectomy, absence of spleen, functional absence of spleen, and any condition resulting from absence of spleen or splenectomy;
Receipt of any of the following products:
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| Name | Affiliation | Role |
|---|---|---|
| Lirong Huang, Bachelor | Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hezhou Center for Disease Prevention and Control | Hezhou | Guangxi | 542699 | China |
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| ID | Term |
|---|---|
| D009107 | Mumps |
| D008457 | Measles |
| ID | Term |
|---|---|
| D019351 | Rubulavirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D009108 | Mumps Vaccine |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| measles, mumps and rubella combined vaccine, live | Biological | One dose of measles, mumps and rubella combined vaccine, live: 0.5 ml per dose, mumps live virus not less than 4.3 lg CCID50 |
|
Safety index, The adverse reactions refers to the adverse events which were considered related to the vaccination
| from day 0 to day 14 after vaccination |
| The incidence of the unsolicited adverse events | Safety Index | from day 0 to day 30 after immunization |
| The incidence of the serious adverse events | Safety Index | from day 0 to day 30 after immunization |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D010309 | Parotitis |
| D010305 | Parotid Diseases |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D018185 | Morbillivirus Infections |