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CompletedNCT02901990Updated Jun 6, 2017

Observational Study to Assess Protection to Mumps in Children Received One-dose Mumps-containing Vaccine

An observational study in Parotid Gland Infection and Fever, sponsored by Jiangsu Province Centers for Disease Control and Prevention. Completed at 6 sites in China. Open to participants aged 3 Years to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-06.

Sponsored by Jiangsu Province Centers for Disease Control and Prevention · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
7,901
Ages
3 Years to 7 Years
Sex
All
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Study 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 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.

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Conditions studied

  • Parotid Gland Infection
  • Fever

Browse trials for

Keywords

  • mumps
  • immunity
  • cohort study
  • children
  • vaccine
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In context

Fever

438 studies on the registry are indexed under Fever; 55 are open to participants now.

This study's enrollment of 7,901 is above the median of 408 across 140 observational studies indexed under Fever.

Browse Fever studies →

Lead sponsor

Jiangsu Province Centers for Disease Control and Prevention is the lead sponsor of 77 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
3 Years to 7 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

children aged 3-7 years who received as least one dose mumps-containing vaccine

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Children aged 3-7 years old;
  2. local resident children living at least 3 months;
  3. physical health, has been vaccinated at least once a dose of MuV

Exclusion criteria

Exclusion Criteria:

  1. did not administer MuV;
  2. refused to collect venous blood;
  3. have been infected with mumps;
  4. have serious illness or other reasons should not participate in the study after clinical evaluation
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
7,901 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

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What researchers measure

Primary outcomes

  1. to describe the sero-prevalence in specific age groups following an active surveillance of vaccinated subjects in each year

    Time frame: 3 years

Secondary outcomes

  1. 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

  2. To characterize the incidence of mumps in specific age groups following an active surveillance of vaccinated subjects in each year

    Time frame: 3 years

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Study locations

6 sites
  • wujin district CDC
    Changzhou, Jiangsu 213000, China
  • lianshui county CDC
    Huaian, Jiangsu 223001, China
  • ganyu district CDC
    Lianyungang, Jiangsu 222002, China
  • gaogang district CDC
    Taizhou, Jiangsu 225300, China
  • tongshan district CDC
    Xuzhou, Jiangsu 221000, China
  • danyang county CDC
    Zhenjiang, Jiangsu 212000, China
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References and documents

Publications

  • Liu 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 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2015 to primary completion in Feb 2017, 16 months.

Of 51 non-industry observational studies under Fever, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 47. This study's 16 months is below that.

Counting every sponsor, half of 61 studies reached it within 22 months; a quarter within 8 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 2, 2016
First posted
Sep 15, 2016
StartActual
Oct 1, 2015
Primary completionActual
Feb 2, 2017
CompletionActual
Feb 2, 2017
Last update
Jun 6, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02901990
Lead sponsor
Jiangsu Province Centers for Disease Control and Prevention
Responsible party
Sponsor
First posted
Sep 15, 2016
Start date
Oct 1, 2015
Primary completion
Feb 2, 2017
Completion
Feb 2, 2017
Last update
Jun 6, 2017

Study contacts

Fenyang Tang
principal investigator · Jiangsu provincial CDC

Oversight

Data monitoring committee
Yes
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 Jun 2017. You cannot join it, but the record below documents what was studied.

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