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. (part of Sinovac Biotech Co., Ltd) · Observational
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.
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.
83 studies on the registry are indexed under Mumps; 8 are open to participants now.
This study's enrollment of 10,000 is above the median of 600 across 11 observational studies indexed under Mumps.
Browse Mumps studies →Sinovac (Dalian) Vaccine Technology Co., Ltd. is the lead sponsor of 20 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
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.
Ran from Oct 2020 to primary completion in Nov 2020, 1 month.
How these figures are worked out, and which studies are left out of them.
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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