Parotid Gland InfectionNCT02901990
Observational Study to Assess Protection to Mumps in Children Received One-dose Mumps-containing Vaccine
An observational study of Parotid Gland Infection and Fever, run by Jiangsu Province Centers for Disease Control and Prevention at 6 sites in China.
Trial summary
This study was aimed to conduct a 3-year perspective study to observe the immunological effect of one-dose mumps-containing vaccine, monitor the incidence of mumps in vaccinated population aged 3-7 years，and provide basis for adjusting MMR immunization strategy in Jiangsu province, China. Read more about this study
- Who is it for?
- Ages 3 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Parotid Gland Infection, Fever
- Type of treatment
- Vaccines
- How many people
- 7,901 participants
- Where
- 6 sitesChina
- Study dates
- 1 Oct 2015to 2 Feb 2017
- 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 3 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: children aged 3-7 years who received as least one dose mumps-containing vaccine
Who may be able to join
- Children aged 3-7 years old;
- local resident children living at least 3 months;
- physical health, has been vaccinated at least once a dose of MuV
Who cannot join
- did not administer MuV;
- refused to collect venous blood;
- have been infected with mumps;
- have serious illness or other reasons should not participate in the study after clinical evaluation
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
wujin district CDC
Changzhou, Jiangsu, 213000
lianshui county CDC
Huaian, Jiangsu, 223001
ganyu district CDC
Lianyungang, Jiangsu, 222002
gaogang district CDC
Taizhou, Jiangsu, 225300
tongshan district CDC
Xuzhou, Jiangsu, 221000
danyang county CDC
Zhenjiang, Jiangsu, 212000
About this study
Official title: Observational Cohort Study to Evaluate Immunogenicity, Protection, and Persistence of Antibody to Mumps in 3-7 Years' Children Received One-dose Mumps-containing Vaccine
This study was aimed to conduct a 3-year perspective study to observe the immunological effect of one-dose mumps-containing vaccine, monitor the incidence of mumps in vaccinated population aged 3-7 years，and provide basis for adjusting MMR immunization strategy in Jiangsu province, China.
Read the detailed description
in 3-7 years old children with high risk of mumps, epidemiological investigation of the serum IgG antibody level were conducted, and then a prospective observational cohort was established in the population with a history of mumps vaccination, and the incidence of mumps in each antibody level group will be observed, the relationship between different antibody levels and the incidence after mumps vaccinated were analyzed, to explore attenuation of mumps IgG antibody levels in the body,S79 vaccine strain against F genotype mumps' antigenic cross-reactivity and the protective effect of antibodies.
- Conditions
- Parotid Gland Infection, Fever
- Keywords
- mumps, immunity, cohort study, children, vaccine
- Medical subject headings
- Fever, Mumps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GMT-low-level group | low geometric mean titer (GMT) detected in the children who had received one-dose mumps-containing vaccine from precious cross sectional study | |
| GMT-high-level group | high geometric mean titer (GMT) detected in the children who had received one-dose mumps-containing vaccine from precious cross sectional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
to describe the sero-prevalence in specific age groups following an active surveillance of vaccinated subjects in each year
Measured: 3 years
Secondary outcomes (2)
to describe wane immunity of IgG antibody to mumps virus in specific age groups following an active surveillance of vaccinated subjects in each year
Measured: 3 years
To characterize the incidence of mumps in specific age groups following an active surveillance of vaccinated subjects in each year
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study start1 Oct 2015
- Primary completion2 Feb 2017
- Study completion2 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parotid Gland InfectionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,901 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Fenyang Tang, Principal investigator, Jiangsu provincial CDC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02901990
- Sponsor's protocol ID
- JSEPI001
- Status last verified
- Jun 2017
- First submitted
- 2 Sep 2016
- Last updated
- 6 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sun J, Li M, Zhang L, Deng X, Hu Y, Chen Q, Wang Z, Sun X, Liu Y. Mumps-specific antibody persistence in children aged 3-7 years immunized with two doses of mumps-containing vaccines: A prospective cohort study in Jiangsu Province, China. Hum Vaccin Immunother. 2023 Dec 31;19(1):2166758. doi: 10.1080/21645515.2023.2166758. Epub 2023 Jan 18.
PubMed 36653029Liu Y, Liu Z, Deng X, Hu Y, Wang Z, Lu P, Guo H, Sun X, Xu Y, Tang F, Zhu FC. Waning immunity of one-dose measles-mumps-rubella vaccine to mumps in children from kindergarten to early school age: a prospective study. Expert Rev Vaccines. 2018 May;17(5):445-452. doi: 10.1080/14760584.2018.1445529. Epub 2018 Mar 12.
PubMed 29478347
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Cohort Study to Evaluate Immunogenicity, Protection, and Persistence of Antibody to Mumps in 3-7 Years' Children Received One-dose Mumps-containing Vaccine
- ClinicalTrials.gov ID
- NCT02901990
- Acronym / sponsor ID
- JSEPI001
- Conditions
- Parotid Gland Infection, Fever
- Keywords
- mumps, immunity, cohort study, children, vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,901 participants (actual)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 2 Feb 2017 (actual)
- Study completion
- 2 Feb 2017 (actual)
- First posted
- 15 Sep 2016 (estimated)
- 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.
This study was aimed to conduct a 3-year perspective study to observe the immunological effect of one-dose mumps-containing vaccine, monitor the incidence of mumps in vaccinated population aged 3-7 years，and provide basis for adjusting MMR immunization strategy in Jiangsu province, China.
Detailed description
in 3-7 years old children with high risk of mumps, epidemiological investigation of the serum IgG antibody level were conducted, and then a prospective observational cohort was established in the population with a history of mumps vaccination, and the incidence of mumps in each antibody level group will be observed, the relationship between different antibody levels and the incidence after mumps vaccinated were analyzed, to explore attenuation of mumps IgG antibody levels in the body,S79 vaccine strain against F genotype mumps' antigenic cross-reactivity and the protective effect of antibodies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GMT-low-level group | – | –low geometric mean titer (GMT) detected in the children who had received one-dose mumps-containing vaccine from precious cross sectional study |
| GMT-high-level group | – | –high geometric mean titer (GMT) detected in the children who had received one-dose mumps-containing vaccine from precious cross sectional study |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- children aged 3-7 years who received as least one dose mumps-containing vaccine
Key inclusion criteria (3 listed)
- Children aged 3-7 years old;
- local resident children living at least 3 months;
- physical health, has been vaccinated at least once a dose of MuV
Key exclusion criteria (4 listed)
- did not administer MuV;
- refused to collect venous blood;
- have been infected with mumps;
- have serious illness or other reasons should not participate in the study after clinical evaluation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
to describe the sero-prevalence in specific age groups following an active surveillance of vaccinated subjects in each year
Time frame: 3 years
2 secondary outcomes
to describe wane immunity of IgG antibody to mumps virus in specific age groups following an active surveillance of vaccinated subjects in each year
Time frame: 3 years
To characterize the incidence of mumps in specific age groups following an active surveillance of vaccinated subjects in each year
Time frame: 3 years
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 Jun 2017.
- Derived from this study: PubMed 36653029Sun J, Li M, Zhang L, Deng X, Hu Y, Chen Q, Wang Z, Sun X, Liu Y. Mumps-specific antibody persistence in children aged 3-7 years immunized with two doses of mumps-containing vaccines: A prospective cohort study in Jiangsu Province, China. Hum Vaccin Immunother. 2023 Dec 31;19(1):2166758. doi: 10.1080/21645515.2023.2166758. Epub 2023 Jan 18.
- Derived from this study: PubMed 29478347Liu Y, Liu Z, Deng X, Hu Y, Wang Z, Lu P, Guo H, Sun X, Xu Y, Tang F, Zhu FC. Waning immunity of one-dose measles-mumps-rubella vaccine to mumps in children from kindergarten to early school age: a prospective study. Expert Rev Vaccines. 2018 May;17(5):445-452. doi: 10.1080/14760584.2018.1445529. Epub 2018 Mar 12.
- Individual participant dataSharing planned: No
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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.
Fenyang Tang principal investigator
Jiangsu provincial CDC
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parotid Gland Infection and Fever, run by Jiangsu Province Centers for Disease Control and Prevention at 6 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 4 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 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
to describe the sero-prevalence in specific age groups following an active surveillance of vaccinated subjects in each year (time frame: 3 years). 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 NCT02901990, which also lists 2 linked publications.
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 Jun 2017.