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

NCT ID: NCT02901990

Last Updated: 2017-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

7901 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-01

Study Completion Date

2017-02-02

Brief Summary

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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

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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

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Parotid Gland Infection Fever

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jiangsu Province Centers for Disease Control and Prevention

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fenyang Tang

Role: PRINCIPAL_INVESTIGATOR

Jiangsu provincial CDC

Locations

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wujin district CDC

Changzhou, Jiangsu, China

Site Status

lianshui county CDC

Huaian, Jiangsu, China

Site Status

ganyu district CDC

Lianyungang, Jiangsu, China

Site Status

gaogang district CDC

Taizhou, Jiangsu, China

Site Status

tongshan district CDC

Xuzhou, Jiangsu, China

Site Status

danyang county CDC

Zhenjiang, Jiangsu, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 36653029 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29478347 (View on PubMed)

Other Identifiers

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JSEPI001

Identifier Type: -

Identifier Source: org_study_id

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