Clinical Trial to Evaluate the Safety and Immunogenicity of Mumps Vaccine

Study Overview
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Brief Summary
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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).

Detailed Description
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The study is a randomized, double-blind, controlled phase Ⅳ 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.

Official Title
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Randomized, Double-blind, Controlled Phase Ⅳ Clinical Trial to Evaluate the Safety and Immunogenicity of Mumps Vaccine in Healthy Infants Aged 8  12 Months.

Conditions
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Mumps

Intervention / Treatment
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* Biological: Mumps vaccine
* Biological: measles, mumps and rubella combined vaccine, live


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers between 8 - 12 months old; Proven legal identity; Written consent of the guardian(s) of the volunteer 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: Any subunit vaccine or inactivated vaccine within 7 days prior to study entry; Any live attenuated vaccine within 28 days prior to study entry; Any other investigational medicine(s) or vaccine within 30 days prior to study entry; Blood product within 3 months prior to study entry; Any immunosuppressant, cytotoxic medicine, or oral corticosteroids; Any of the acute disease or attack of the chronic disease within 7 days; Pregnant in cohabitants or congenital immune diseases; Based on the judgment of investigator(s), there was any condition indicating that the subject should be excluded

Ages Eligible for Study
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Minimum Age: 8 Months
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Mumps vaccine, one dose | Biological: Mumps vaccine<br>* One dose of mumps vaccine: 0.5 ml per dose, mumps live virus not less than 3.7 lg CCID50<br>|
| Active Comparator: Control group<br>measles, mumps and rubella combined vaccine, live, one dose | Biological: measles, mumps and rubella combined vaccine, live<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mumps, Mumps vaccine, measles, mumps and rubella combined vaccine, live, infants