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

Mumps Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05145166
• Other study ID #: PRO-MUMPS-4007
• Status: Completed
• 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
• 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: -

Related Conditions & MeSH terms

• Mumps

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.