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

Completed

• Conditions: Dengue Hemorrhagic Fever; Dengue; Dengue Fever

• Registration Number: NCT01477671
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-11-18
• Study First Submitted QC: 2011-11-18
• Study First Posted: 2011-11-22
• Primary Completion: 2012-09
• Study Completion: 2013-12
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-09
• Last Update Posted: 2018-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 667

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of positive samples with dengue specific serotype DENV 1, 2,3 and/or 4	Baseline

Secondary Outcome Measures

Name	Time	Method
Prevalence of positive serum samples with JEV specific IgG antibodies	Baseline