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

Observational Cohort Study to Evaluate Immunogenicity, Protection, and Persistence of Antibody to Mumps in 3-7 Years' Children Received One-dose Mumps-containing Vaccine

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02901990

Enrollment

7901

Registered

2016-09-15

Start date

2015-10-01

Completion date

2017-02-02

Last updated

2017-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fever, Parotid Gland Infection

Keywords

mumps, immunity, cohort study, children, 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

3 Years to 7 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

China

Outcome results