Prospective Dengue Seroprevalence Study in 5 to 10 Year-old Children

Sanofi

Status: Completed

Conditions: Dengue Hemorrhagic Fever; Dengue Fever; Dengue

Study type: Observational

Funder types: Industry

Identifiers

NCT01477671

U1111-1124-7423 (Other Identifier)

DNG10

Details and patient eligibility

About

This is a descriptive prospective community-based seroprevalence study.

Primary objective:

• To determine the prevalence of specific antibodies (immunoglobulin G [IgG]) against dengue in healthy 5 to 10 year-old children in India.

Secondary objectives:

• To determine the dengue virus serotype (DeNV-1,2,3 and /or 4) specific to the antibodies in positive (IgG) samples
• To estimate the prevalence of specific antibodies (IgG) against Japanese encephalitis in healthy 5 to 10 year-old children in India.

Enrollment: 667 patients

Sex: All

Ages: 5 to 10 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Aged between 5 and 10 year-old on the day of inclusion
• Healthy child as reported by the parent or legally qualified guardian
• Being registered in selected study site
• Provision of the informed consent form signed by at least one parent or legally qualified guardian
• For children between 8 and 10 years old, provision of the assent form signed.

Exclusion criteria

• N/A

Trial design

667 participants in 1 patient group

Study Group

Description:

Participants aged between 5 and 10 year-old on day of inclusion.