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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02901990
Recruitment Status : Completed
First Posted : September 15, 2016
Last Update Posted : June 6, 2017
Sponsor:
Information provided by (Responsible Party):
Jiangsu Province Centers for Disease Control and Prevention

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.

Condition or disease
Parotid Gland Infection Fever

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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Study Type : Observational
Actual Enrollment : 7901 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : October 1, 2015
Actual Primary Completion Date : February 2, 2017
Actual Study Completion Date : February 2, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mumps

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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Biospecimen Retention:   Samples Without DNA
blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 7 Years   (Child)
Sexes Eligible for Study:   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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901990


Locations
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China, Jiangsu
wujin district CDC
Changzhou, Jiangsu, China, 213000
lianshui county CDC
Huaian, Jiangsu, China, 223001
ganyu district CDC
Lianyungang, Jiangsu, China, 222002
gaogang district CDC
Taizhou, Jiangsu, China, 225300
tongshan district CDC
Xuzhou, Jiangsu, China, 221000
danyang county CDC
Zhenjiang, Jiangsu, China, 212000
Sponsors and Collaborators
Jiangsu Province Centers for Disease Control and Prevention
Investigators
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Principal Investigator: Fenyang Tang Jiangsu provincial CDC

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jiangsu Province Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT02901990     History of Changes
Other Study ID Numbers: JSEPI001
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: June 6, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiangsu Province Centers for Disease Control and Prevention:
mumps
immunity
cohort study
children
vaccine
Additional relevant MeSH terms:
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Mumps
Rubulavirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Parotitis
Parotid Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs