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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05145166
Other study ID # PRO-MUMPS-4007
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 6, 2020
Est. completion date March 25, 2021

Study information

Verified date November 2021
Source Sinovac (Dalian) Vaccine Technology Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 10000
Est. completion date March 25, 2021
Est. primary completion date November 6, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 14 Years
Eligibility 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: -

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
China 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

Sponsors (1)

Lead Sponsor Collaborator
Sinovac (Dalian) Vaccine Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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.
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