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CompletedNCT05145166Updated Dec 6, 2021

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

An observational study in Mumps, sponsored by Sinovac (Dalian) Vaccine Technology Co., Ltd.. Completed at 3 sites in China. Open to participants aged Up to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-06.

Sponsored by Sinovac (Dalian) Vaccine Technology Co., Ltd. · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
10,000
Ages
Up to 14 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Mumps

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Who can participate

Ages eligible
Up to 14 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

Exclusion Criteria:

-

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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
10,000 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • BiologicalSafety 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: From 0 day to 14 days after vaccination

  2. 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.

    Time frame: From 0 day to 30 days after vaccination.

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Study locations

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

Key details

Study ID
NCT05145166
Lead sponsor
Sinovac (Dalian) Vaccine Technology Co., Ltd.
Responsible party
Sponsor
First posted
Dec 6, 2021
Start date
Oct 6, 2020
Primary completion
Nov 6, 2020
Completion
Mar 25, 2021
Last update
Dec 6, 2021

Study contacts

Weijun Hu, Master
principal investigator · Shaanxi Provincial Center for Disease Control and Prevention

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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