MumpsNCT05145166

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

An observational study of Mumps, run by Sinovac (Dalian) Vaccine Technology Co., Ltd. at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages Up to 14 yearsHealthy volunteers can take part
Conditions the study is for: Mumps
What is being tested?: Safety group
Type of treatment: Vaccines, Injection or infusion
How many people: 10,000 participants
Where: 3 sitesChina
Study dates: 6 Oct 2020to 25 Mar 2021
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 14 years
All sexes
Healthy volunteers accepted
Child

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.

Who may be able to join

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)

Who cannot join

Trial locations and contacts

3 sites in 1 country.

China3 sites

Baoji Center for Disease Prevention and Control
Baoji, Shanxi, 721006
Xianyang Center for Disease Control and Prevention
Xianyang, Shanxi, 712000
Yanan Center for Disease Prevention and Control
Yan’an, Shanxi, 716000

Other trials in China

About this study

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

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.

Conditions: Mumps
Being tested: Safety group
Medical subject headings: Mumps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Safety groupBiological
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: From 0 day to 30 days after vaccination.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Oct 202025 Mar 2021

First posted6 Dec 2021
Study start6 Oct 2020
Primary completion6 Nov 2020
Study completion25 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for MumpsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 10,000 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05145166
Sponsor's protocol ID: PRO-MUMPS-4007
Status last verified: Nov 2021
First submitted: 25 Nov 2021
Last updated: 6 Dec 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 37733724

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Mumps trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05145166
Acronym / sponsor ID: PRO-MUMPS-4007
Conditions: Mumps
Study type: Observational
Recruitment status: Completed
Enrolment: 10,000 participants (actual)
Lead sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd.Industry (pharma, biotech, devices)
Study start: 6 Oct 2020 (actual)
Primary completion: 6 Nov 2020 (actual)
Study completion: 25 Mar 2021 (actual)
First posted: 6 Dec 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Observational model: Case only
Time perspective: Prospective

Who may qualify

Ages: Up to 14 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child
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.

Key inclusion criteria (3 listed)

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)

Key exclusion criteria (1 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Safety groupAll 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.	Biological	–

Primary outcome

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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
Derived from this study: PubMed 37733724Hu 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.

Related trials for Mumps

RecruitingPhase 4
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Not yet recruitingPhase 3
A Study on the Immune Response and Safety of an Investigational Combined Measles, Mumps, Rubella and Varicella Vaccine, When Given to Healthy Children 4 to 6 Years of Age
Measles, Mumps
RecruitingPhase 3
A Study on the Immune Response and Safety of an Investigational Combined Measles, Mumps, Rubella and Varicella Vaccine, When Administered as Intramuscular Injection to Healthy Children 15 Months to 6 Years of Age
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RecruitingPhase 3
A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine and a Marketed Measles, Mumps and Rubella Vaccine When Administered as Intramuscular Injection to Healthy Children 12 to 15 Months of Age
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Weijun Hu, Master principal investigator

Shaanxi Provincial Center for Disease Control and Prevention

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Mumps, run by Sinovac (Dalian) Vaccine Technology Co., Ltd. at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety index-the incidence of local and systemic adverse reactions (time frame: From 0 day to 14 days after vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05145166, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021.