Clinical trial NCT05145166: Safety Study of Live Attenuated Mumps Vaccines in Junior High School Students Under 14 Years Old
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mumps
Lead sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-12-06
Enrollment: 10000
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this study, only junior high school students under 14 years old who were judged by vaccination doctors to be eligible for vaccination and voluntarily received one dose of live attenuated mumps vaccine were enrolled.

Brief summary: 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: 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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Safety index-the incidence of local and systemic adverse reactions
timeFrame: From 0 day to 14 days after vaccination
measure: Safety index-The incidence of local and systemic adverse reactions
timeFrame: From 0 day to 30 days after vaccination.
Secondary outcomes:
Other outcomes:
Locations:
city: Baoji
country: China
facility: Baoji Center for Disease Prevention and Control
state: Shanxi
city: Xianyang
country: China
facility: Xianyang Center for Disease Control and Prevention
state: Shanxi
city: Yan'an
country: China
facility: Yanan Center for Disease Prevention and Control
state: Shanxi
Study officials:
affiliation: Shaanxi Provincial Center for Disease Control and Prevention
name: Weijun Hu, Master
role: PRINCIPAL_INVESTIGATOR
References: