Clinical Trial: Prospective Dengue Seroprevalence Study in 5 to 10 Year-old Children
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Prospective Dengue Seroprevalence Study in 5 to 10 Year-old Children in India
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 Summary:
Sponsor: Sanofi Pasteur, a Sanofi Company
Current Primary Outcome: Prevalence of positive samples with dengue specific serotype DENV 1, 2,3 and/or 4 [ Time Frame: Baseline ]
Original Primary Outcome: Percentage of participants with dengue specific IgG antibodies in serum samples [ Time Frame: Day 0 ]
Current Secondary Outcome: Prevalence of positive serum samples with JEV specific IgG antibodies [ Time Frame: Baseline ]
Original Secondary Outcome:
- Prevalence of positive samples with dengue specific serotype DENV 1, 2,3 and/or 4 [ Time Frame: Day 0 ]
- Prevalence of positive serum samples with JEV specific IgG antibodies [ Time Frame: Day 0 ]
Information By: Sanofi
Dates:
Date Received: November 18, 2011
Date Started: September 2011
Date Completion:
Last Updated: April 25, 2014
Last Verified: April 2014
