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

NCT ID: NCT05145166

Last Updated: 2021-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-06

Study Completion Date

2021-03-25

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.

Conditions

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Mumps

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type BIOLOGICAL

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

\-
Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sinovac (Dalian) Vaccine Technology Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Weijun Hu, Master

Role: PRINCIPAL_INVESTIGATOR

Shaanxi Provincial Center for Disease Control and Prevention

Locations

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Baoji Center for Disease Prevention and Control

Baoji, Shanxi, China

Site Status

Xianyang Center for Disease Control and Prevention

Xianyang, Shanxi, China

Site Status

Yanan Center for Disease Prevention and Control

Yan’an, Shanxi, China

Site Status

Countries

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China

References

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Hu W, Jia N, Meng W, Zhou T, Wang R, Xiong Y, Luan C, Zhang S. Safety analysis of a live attenuated mumps vaccine in healthy adolescents in China: A phase 4, observational, open-label trial. PLoS One. 2023 Sep 21;18(9):e0291730. doi: 10.1371/journal.pone.0291730. eCollection 2023.

Reference Type DERIVED
PMID: 37733724 (View on PubMed)

Other Identifiers

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PRO-MUMPS-4007

Identifier Type: -

Identifier Source: org_study_id