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Completed

NCT Number: NCT01477671

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

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.

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Key information

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kalyani, West Bengali, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Prevalence of positive samples with dengue specific serotype DENV 1, 2,3 and/or 4

    Time frame: Baseline

Secondary outcomes

  1. Prevalence of positive serum samples with JEV specific IgG antibodies

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Nov 22, 2011
Registry last updated
Jan 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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