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

Sinovac (Dalian) Vaccine Technology Co., Ltd.10,000 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

10,000

Conditions

Mumps

Interventions

Eligibility

Sex: ALLMax age: 14 YearsHealthy volunteers:

Medical Language ↔ Plain English

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: \-

Locations (3)

Baoji Center for Disease Prevention and Control

Baoji, Shanxi, China

Xianyang Center for Disease Control and Prevention

Xianyang, Shanxi, China

Yanan Center for Disease Prevention and Control

Yan’an, Shanxi, China

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: From 0 day to 30 days after vaccination.