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

Completed

• Conditions: Parotid Gland Infection; Fever

• Registration Number: NCT02901990
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-10-01
• Study First Submitted: 2016-09-02
• Study First Submitted QC: 2016-09-11
• Study First Posted: 2016-09-15
• Primary Completion: 2017-02-02
• Study Completion: 2017-02-02
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-04
• Last Update Posted: 2017-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7901

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
to describe the sero-prevalence in specific age groups following an active surveillance of vaccinated subjects in each year	3 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (6)

lianshui county CDC; 🇨🇳 Huaian, Jiangsu, China

ganyu district CDC; 🇨🇳 Lianyungang, Jiangsu, China

tongshan district CDC; 🇨🇳 Xuzhou, Jiangsu, China

wujin district CDC; 🇨🇳 Changzhou, Jiangsu, China

gaogang district CDC; 🇨🇳 Taizhou, Jiangsu, China

danyang county CDC; 🇨🇳 Zhenjiang, Jiangsu, China