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

Fever Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02901990
• Other study ID #: JSEPI001
• Status: Completed
• Phase: N/A
• First received: September 2, 2016
• Last updated: June 4, 2017
• Start date: October 1, 2015
• Est. completion date: February 2, 2017

Study information

• Verified date: June 2017
• Source: Jiangsu Province Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7901
• Est. completion date: February 2, 2017
• Est. primary completion date: February 2, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Fever
• Parotid Gland Infection

Locations

Country	Name	City	State
China	wujin district CDC	Changzhou	Jiangsu
China	lianshui county CDC	Huaian	Jiangsu
China	ganyu district CDC	Lianyungang	Jiangsu
China	gaogang district CDC	Taizhou	Jiangsu
China	tongshan district CDC	Xuzhou	Jiangsu
China	danyang county CDC	Zhenjiang	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Province Centers for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to describe the sero-prevalence in specific age groups following an active surveillance of vaccinated subjects in each year		3 years
Secondary	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
Secondary	To characterize the incidence of mumps in specific age groups following an active surveillance of vaccinated subjects in each year		3 years