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

November 25, 2021 updated by: Sinovac (Dalian) Vaccine Technology Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanxi
      • Baoji, Shanxi, China, 721006
        • Baoji Center for Disease Prevention and Control
      • Xianyang, Shanxi, China, 712000
        • Xianyang Center for Disease Control and Prevention
      • Yan'an, Shanxi, China, 716000
        • Yanan Center for Disease Prevention and Control

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 14 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sinovac (Dalian) Vaccine Technology Co., Ltd.

Investigators

  • Principal Investigator: Weijun Hu, Master, Shaanxi Provincial Center for Disease Control and Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 6, 2020

Primary Completion (ACTUAL)

November 6, 2020

Study Completion (ACTUAL)

March 25, 2021

Study Registration Dates

First Submitted

November 25, 2021

First Submitted That Met QC Criteria

November 25, 2021

First Posted (ACTUAL)

December 6, 2021

Study Record Updates

Last Update Posted (ACTUAL)

December 6, 2021

Last Update Submitted That Met QC Criteria

November 25, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO-MUMPS-4007

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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