Safety Study of Live Attenuated Mumps Vaccines in Junior High School Students Under 14 Years Old

Study Overview
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Brief Summary
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This study of live attenuated mumps vaccines is an observational study in which active monitoring and passive monitoring were combined to conduct safety observation.The live attenuated mumps vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.The purpose of this study is to evaluate the safety of live attenuated mumps vaccines after large-scale application and accumulate safety data for the application of live attenuated mumps vaccines,and provide scientific basis for the formulation of vaccine immunization prevention strategies.

Detailed Description
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This study of live attenuated mumps vaccines is an observational study in which active monitoring and passive monitoring were combined to conduct safety observation.The live attenuated mumps vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.Bao'ji, Xian'yang, Yan 'an and Han'zhong of Shaanxi Province were selected as the research center.A total of 10000 junior high school students under 14 years old who voluntarily received a dose of live attenuated mumps vaccines were be enrolled.Adverse reactions/events at 30 minutes, 14 days and 30 days after vaccination of live attenuated mumps vaccine were were collected by face-to-face or telephone follow-up.

Official Title
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Safety Observation of Live Attenuated Mumps Vaccines in Junior High School Students Under 14 Years Old Vaccinated With Live Attenuated Mumps Vaccines in Shanxi Province

Conditions
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Mumps

Intervention / Treatment
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* Biological: Safety group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Junior high school students under 14 years old; The subjects and guardians of the subjects can understand and voluntarily sign the informed consent form ; Subjects and their legal guardians are able to attend follow-up visits and follow all study procedures (such as cooperating in completing safety observation notes) Exclusion Criteria: -

Ages Eligible for Study
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Maximum Age: 14 Years

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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Safety group|All of the participants(N=10000) received one dose of live attenuated mumps vaccine.Vaccine will given by single intramuscular injection(0.5 ml) on day 0.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety index-the incidence of local and systemic adverse reactions | The incidence of local and systemic adverse reactions from 0 day to 14 days after vaccination. | From 0 day to 14 days after vaccination | 
| Safety index-The incidence of local and systemic adverse reactions | The incidence of local and systemic adverse reactions from 0 day to 30 days after vaccination. | From 0 day to 30 days after vaccination. |