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

June 4, 2017 updated by: Jiangsu Province Centers for Disease Control and Prevention

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

7901

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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:

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
to describe the sero-prevalence in specific age groups following an active surveillance of vaccinated subjects in each year
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Province Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Fenyang Tang, Jiangsu provincial CDC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

February 2, 2017

Study Completion (Actual)

February 2, 2017

Study Registration Dates

First Submitted

September 2, 2016

First Submitted That Met QC Criteria

September 11, 2016

First Posted (Estimate)

September 15, 2016

Study Record Updates

Last Update Posted (Actual)

June 6, 2017

Last Update Submitted That Met QC Criteria

June 4, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JSEPI001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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