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

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.

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Key information

Conditions

Mumps Infections Mononegavirales Infections Mouth Diseases Paramyxoviridae Infections Parotid Diseases Parotitis RNA Virus Infections Rubulavirus Infections Salivary Gland Diseases Stomatognathic Diseases Virus Diseases

Age range

Up to 14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Baoji Center for Disease Prevention and Control, Baoji, Shanxi, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Safety group

Biological

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.

Primary outcomes

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.
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.

Sponsors and collaborators

Lead sponsor

Sinovac (Dalian) Vaccine Technology Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2021
First posted: Dec 6, 2021
Registry last updated: Dec 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed