NCT02901990

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,901

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2017

Completed
Last Updated

June 6, 2017

Status Verified

June 1, 2017

Enrollment Period

1.3 years

First QC Date

September 2, 2016

Last Update Submit

June 4, 2017

Conditions

Parotid Gland InfectionFever

Keywords

mumpsimmunitycohort studychildrenvaccine

Outcome Measures

Primary Outcomes (1)

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

    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

    3 years

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

    3 years

Study Arms (2)

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

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

wujin district CDC

Changzhou, Jiangsu, 213000, China

Location

lianshui county CDC

Huaian, Jiangsu, 223001, China

Location

ganyu district CDC

Lianyungang, Jiangsu, 222002, China

Location

gaogang district CDC

Taizhou, Jiangsu, 225300, China

Location

tongshan district CDC

Xuzhou, Jiangsu, 221000, China

Location

danyang county CDC

Zhenjiang, Jiangsu, 212000, China

Location

Related Publications (2)

  • 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.

    PMID: 36653029DERIVED

  • 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.

    PMID: 29478347DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

MeSH Terms

Conditions

FeverMumps

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsRubulavirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsParotitisParotid DiseasesSalivary Gland DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Fenyang Tang

    Jiangsu provincial CDC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2016

First Posted

September 15, 2016

Study Start

October 1, 2015

Primary Completion

February 2, 2017

Study Completion

February 2, 2017

Last Updated

June 6, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(6)