Clinical trial NCT02901990: Observational Study to Assess Protection to Mumps in Children Received One-dose Mumps-containing Vaccine
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parotid Gland Infection
Fever
Keywords: mumps
immunity
cohort study
children
vaccine
Lead sponsor: Jiangsu Province Centers for Disease Control and Prevention
Sponsor class: NETWORK
First posted: 2016-09-15
Enrollment: 7901
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: children aged 3-7 years who received as least one dose mumps-containing vaccine

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.

Eligibility 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

Primary outcomes:
measure: to describe the sero-prevalence in specific age groups following an active surveillance of vaccinated subjects in each year
timeFrame: 3 years
Secondary outcomes:
measure: to describe wane immunity of IgG antibody to mumps virus in specific age groups following an active surveillance of vaccinated subjects in each year
timeFrame: 3 years
measure: To characterize the incidence of mumps in specific age groups following an active surveillance of vaccinated subjects in each year
timeFrame: 3 years
Other outcomes:
Locations:
city: Changzhou
country: China
facility: wujin district CDC
state: Jiangsu
city: Huaian
country: China
facility: lianshui county CDC
state: Jiangsu
city: Lianyungang
country: China
facility: ganyu district CDC
state: Jiangsu
city: Taizhou
country: China
facility: gaogang district CDC
state: Jiangsu
city: Xuzhou
country: China
facility: tongshan district CDC
state: Jiangsu
city: Zhenjiang
country: China
facility: danyang county CDC
state: Jiangsu
Study officials:
affiliation: Jiangsu provincial CDC
name: Fenyang Tang
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.